Protocol. This trial protocol has been provided by the authors to give readers additional information about their work.
|
|
- Stephen Clark
- 6 years ago
- Views:
Transcription
1 Protocol This trial protocol has been provided by the authors to give readers additional information about their work. Protocol for: Sihvonen R, Paavola M, Malmivaara A, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med 2013;369: DOI: /NEJMoa
2 Supplementary Material Arthroscopic Partial Meniscectomy vs. Sham for a Degenerative Meniscus Tear by Raine Sihvonen, Mika Paavola, Antti Malmivaara, Ari Itälä, Antti Joukainen, Heikki Nurmi, Juha Kalske and Teppo LN Järvinen On behalf of the FIDELITY (Finnish Degenerative Meniscal Lesion Study) Group CONTRIBUTORS, the FIDELITY Group: Jukka Nyrhinen, MD (Central Finland Central Hospital, Jyväskylä) Timo Järvelä, MD, PhD; Tero Järvinen MD, PhD; Janne Lehtinen, MD, PhD; Marko Raivio, MD (Hatanpää City Hospital, Tampere) Janne Karhunen, MD; Sikri Tukiainen, MD (Helsinki University Central Hospital/Jorvi Hospital, Espoo) Heikki Kröger, MD, PhD (Kuopio University Hospital, Kuopio) Ville Äärimaa, MD, PhD (Turku University Hospital, Turku) This supplement contains the following items 1. Protocol a. Original protocol b. Final protocol c. Summary of amendments 2. Statistical analysis plan a. Original statistical analysis plan b. Final statistical analysis plan c. Summary of amendments
3 1. PROTOCOL 1a. Original protocol Original protocol submitted to Clinical Trials.gov on October 24, 2007 can be accessed at: This same information is copied below: First Received Date (At Clinical Trials.gov) October 24, 2007 Start Date October 2007 Estimated Primary Completion Date January 2013 (final data collection date for primary outcome measure) Primary Outcome Measures: The Lysholm knee score (Time Frame: One year) Pain at rest and activity (VAS) (Time Frame: One year) Secondary Outcome Measures WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) (Time Frame: One year) 15-D (general quality of life -assessment tool) (Time Frame: One year) Descriptive Information Brief Title: Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear Official Title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee Brief Summary Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. Detailed Description
4 Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a diseasespecific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis. Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment Condition: Degenerative Tear of the Medial Meniscus of Knee Intervention: Procedure: Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus Procedure: Conservative (diagnostic arthroscopy): Diagnostic arthroscopy Study Arms: Active Comparator: Operative (O): Partial resection of degenerative tear of medial meniscus Intervention: Procedure: Operative (partial arthroscopy) Sham Comparator: Conservative (K): Arthroscopy (diagnostic) Intervention: Procedure: Conservative (diagnostic arthroscopy) Estimated Enrollment: 140 Eligibility Criteria:
5 Inclusion Criteria: 1. Age: 35 to 65 years of age. 2. A pain located on the medial joint line of the knee that has persistent at least for 3 months. 3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign. 4. Tear of the medial meniscus on MRI. 5. Degenerative rupture of the medial meniscus confirmed at arthroscopy. Exclusion Criteria: 1. Acute, trauma-induced onset of symptoms. 2. Locking or painful snapping of the knee joint. 3. A surgical operation performed on the affected knee. 4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR). 5. Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1). 6. Acute (within the previous year) fractures of the knee. 7. Decreased range of motion of the knee. 8. Instability of the knee. 9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment. 10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention. Gender: Both Ages: 35 Years to 65 Years Location, Countries: Hatanpää City Hospital, Tampere, Finland Data Monitoring Committee: Yes Study Chair: Teppo LN Jarvinen, MD, PhD, University of Tampere Principal Investigator: Raine TA Sihvonen, MD, Tampere City Hospital Study Director: Mika Paavola, MD, PhD, Helsinki University Study Director: Antti Malmivaara, MD, PhD, Helsinki
6 1b. Final protocol Amended sections only (the final protocol was published in its entirety in Sihvonen et al 1 ) Primary Outcome Measures: (Changes in the score) The Lysholm knee score (Time Frame: One year) WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) (Time Frame: One year) Pain after exercise (NRS) (Time Frame: One year) Secondary Outcome Measures (Time Frame: One year) 15-D (general quality of life -assessment tool)(time Frame: One) Pain at rest (NRS) (Time Frame: One year) Eligibility Criteria: Inclusion Criteria: 1. Age: 35 to 65 years of age. 2. A pain located on the medial joint line of the knee that has persistent at least for 3 months. 3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign. 4. Tear of the medial meniscus on MRI. 5. Degenerative rupture of the medial meniscus confirmed at arthroscopy. Exclusion Criteria: 1. Acute, trauma-induced onset of symptoms. 2. Locked knee (that cannot be straightened normally). 3. A surgical operation performed on the affected knee. 4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR). 5. Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1). 6. Acute (within the previous year) fractures of the knee. 7. Decreased range of motion of the knee. 8. Instability of the knee.
7 9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment. 10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention. Location, Countries: (Changed at January 19, 2010) Hatanpää City Hospital, Tampere, Finland Helsinki University Central Hospital, Helsinki, Finland Kuopio University Hospital, Kuopio, Finland Turku University Hospital, Turku, Finland Central Hospital of Central Finland Hospital District, Jyväskylä, Finland Data Monitoring Committee: Yes Study Chair: Teppo LN Jarvinen, MD, PhD, University of Tampere Principal Investigator: Raine TA Sihvonen, MD, Tampere City Hospital Study Director: Mika Paavola, MD, PhD, Helsinki University Study Director: Antti Malmivaara, MD, PhD, Helsinki University Collaborators Helsinki University Central Hospital Kuopio University Hospital Turku University Hospital Central Finland Hospital District
8 1c. Summary of amendments 1) Primary and secondary outcomes WOMET upgraded as a primary outcome Pain assessment o Pain after exercise specified as a primary outcome o Pain at rest specified as a secondary outcome When we registered the trial in ClinicalTrials.com, our two primary outcome measures were the Lysholm knee score and the Pain at rest and activity (using the visual analogue scale, VAS) at 12 months after surgery. The secondary outcomes were the WOMET score and a cost-utility analysis (based on the patients general quality of life using the 15D score and the utilization of healthcare resources), both also at 12 months after surgery. The Lysholm score was chosen as our primary outcome as it was validated for meniscus injury and it was (and still is) the most often used knee outcome instrument. However, during the recruitment phase of our trial, we validated the WOMET in this particular patient population (patients with a degenerative meniscus injury), 2 and as the WOMET is a disease-specific QoL instrument and showed at least comparable (if not better) psychometric properties to the Lysholm score, we decided to add it as our third primary outcome. Finally, we initially registered both Pain at rest and activity (VAS) as primary outcome(s). However, after realizing that this was somewhat ambiguous, we chose to specify that Pain after exercise was a primary outcome (as being more important of the two to patients with degenerative meniscus tear) and Pain at rest a secondary outcome. On this note, our method to query pain was actually NRS (Numerical rating scale), rather than VAS (visual analogue scale). As per the request of the NEJM, this amendment was also updated to the ClinicalTrials.com database (August 1, 2013) to make the registration concordant with the paper/reported outcomes. 2) Exclusion criteria: (locking to locked) The terminology related to mechanical symptoms of the knee is vague, at best. When planning our trial, we were advised by the local IRB that our sham surgery controlled design cannot pose a medical risk to the patients, and accordingly, patients with an absolute indication for knee arthroscopy have to be operated on (i.e., excluded). To conform to this requirement, we listed a painful snapping or locking as one of our exclusion criterion. However, as patients with a degenerative meniscus tear (even without radiographic or clinical OA) quite frequently report of various mechanical symptoms (such as sensations of catching, snapping or locking), but rarely have (episodes of) locked knee (meaning that they cannot extend their knee fully), patients with mechanical symptoms were enrolled right from the beginning. When extending our trial from the initial study center (Tampere) to four other centers, this particular exclusion criterion (expression) was discussed in detail to make sure that all doctors enroll identical patients. It was subsequently agreed that we should rephrase the exclusion criterion as follows: Locked knee (that cannot be straightened normally). As you can appreciate, our study sample includes patients with mechanical
9 symptoms (locking or catching, Table 2.), but those with (episodes of) locked knee were excluded (Figure 1.). 3) Sites: The trial began in only one center (Tampere), but once the study protocol had been thoroughly refined, it was expanded to four additional sites to increase the enrollment rate and also, to minimize possible bias and criticism for having only one surgeon performing all operations. This amendment was made to the ClinicalTrials.com database on January 19, Be it reiterated here that all the above noted amendments to the original protocol were made prior to completion of the trial and have been elaborated in detail in our published protocol paper 1.
10 2. STATISTICAL ANALYSIS PLAN 2a. Original statistical analysis plan A description of our original statistical analysis plan was published 1 as follows: The trial was designed to ascertain the superiority of APM over placebo at 12 months with primary outcome measures by the means of statistically significant differences between the groups. Baseline characteristics will be analysed by descriptive statistics. For the primary analysis, the change in scores (Lysholm and WOMET) and pain (NRS) at 12 months will be compared between the two study groups. A secondary analysis of the primary endpoint will adjust for those prerandomisation variables which might reasonably be expected to influence the outcome (ie, sex, age, radiological OA and baseline score). A two-sided p value of 0.05 will be considered to indicate statistical significance. We will use the Bonferroni method to appropriately adjust the overall level of significance for multiple (three) primary outcomes. Analyses of the outcome measures score will also be performed at 2 and 6 months. Additionally, the number and percentage of satisfied patients, those subjectively improved, and those whose allocation was unsealed will be calculated and compared between the two groups. All statistical analyses will be performed on an intention-to-treat basis, meaning that data from patients will be analysed according to the initial study-group assignment regardless of compliance with randomisation. However, as the potential for treatment conversion exists, but only from placebo surgery to APM, per-protocol analysis will also be carried out. We plan to conduct a subgroup analysis to compare the result based on the degree of radiographic OA (K&L 0 vs I). The serious adverse event rates occurring within 12 months of surgery for both study arms will be evaluated descriptively in aggregate and separately. If the number of events is large enough to allow more sophisticated analysis, the rates between the APM and placebo arms will be compared. The data will be presented by the total number of events and the total number of individuals with at least one event. 2b. Final statistical analysis plan A detailed description of the execution of the statistical analysis can be found in our Blinded Data Analyses Statement of Interpretation -document (Supplementary Appendix of our submission). Be it reiterated here that the entire statistical analysis was carried out blinded and the randomization code was broken only after the main findings/interpretation of the results were mutually agreed on (and documented) by the entire manuscript writing committee. 2c. Summary of amendments We used medians (range) to carry out the statistical analysis/data interpretation (as the data of our primary outcomes is not normally distributed), but reported it using means with 95% confidence
11 intervals to conform with the apparent policy of the New England Journal of Medicine to prefer this format. References 1. Sihvonen R, Paavola M, Malmivaara A, Jarvinen TL. Finnish Degenerative Meniscal Lesion Study(FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design. BMJ open 2013;3. 2. Sihvonen R, Jarvela T, Aho H, Jarvinen TL. Validation of the Western Ontario Meniscal Evaluation Tool (WOMET) for patients with a degenerative meniscal tear: a meniscal pathologyspecific quality-of-life index. The Journal of bone and joint surgery American volume 2012;94:e65.
Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a. blinded, randomised placebo surgery controlled
Open Access To cite: Sihvonen R, Paavola M, Malmivaara A, et al. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of
More informationFinnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a. blinded, randomised placebo surgery controlled
Open Access To cite: Sihvonen R, Paavola M, Malmivaara A, et al. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of
More informationArthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear
https://helda.helsinki.fi Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear Sihvonen, Raine 2018-02 Sihvonen, R, Paavola, M, Malmivaara, A, Itälä, A, Joukainen,
More informationManagement of the Early Degenerate Knee. Kieran Barnard Hip and Knee Pathway Lead
Management of the Early Degenerate Knee Kieran Barnard Hip and Knee Pathway Lead This history Moseley et al (2002) Randomised placebo controlled trial. A total of 180 patients with osteoarthritis of the
More informationArthroscopic Partial Meniscectomy versus Sham Surgery for a Degenerative Meniscal Tear
The new england journal of medicine original article Arthroscopic Partial Meniscectomy versus Sham Surgery for a Degenerative Meniscal Tear Raine Sihvonen, M.D., Mika Paavola, M.D., Ph.D., Antti Malmivaara,
More informationNon-Surgical vs. Surgical Treatment of Meniscus Tears of the Knee
Non-Surgical vs. Surgical Treatment of Meniscus Tears of the Knee Greg I. Nakamoto, MD FACP Section of Orthopedics and Sports Medicine Virginia Mason Medical Center CASE 1 45 y/o construction worker sent
More informationArthroscopic Debridement of the Knee: An Evidence Update
Arthroscopic Debridement of the Knee: An Evidence Update Evidence Development and Standards Branch, Health Quality Ontario November 2014 Ontario Health Technology Assessment Series; Vol. 14: No. 13, pp.
More informationNHS Birmingham and Solihull Clinical Commissioning Group. DRAFT Policy for Knee Arthroscopy for Degenerative Knee Disease
NHS Birmingham and Solihull Clinical Commissioning Group DRAFT Policy for Knee Arthroscopy for Degenerative Knee Disease 1 Document Details: Version: DRAFT v3. Ratified by (name and date of Committee):
More informationTHE PLACE OF ARTHROSCOPY IN DEGENERATIVE KNEE PAIN WITHOUT TRUE LOCKING IN ADULTS
1 EVIDENCE SUMMARY REPORT THE PLACE OF ARTHROSCOPY IN DEGENERATIVE KNEE PAIN WITHOUT TRUE LOCKING IN ADULTS Question to be addressed Is there evidence that arthroscopic investigation and treatment of the
More informationLondon Choosing Wisely
London Choosing Wisely Draft Policy Template: Knee arthroscopy Version Date Notes Draft for T&F Group 1 03/05/18 Initial draft Revised version post T&F Group 1 Revised version for Task & Finish Group 2
More information6/30/2015. Quadriceps Strength is Associated with Self-Reported Function in Arthroscopic Partial Meniscectomy Patients. Surgical Management
Quadriceps Strength is Associated with Self-Reported Function in Arthroscopic Partial Meniscectomy Patients Meniscal tears no cause for concern? Among the most common injuries of the knee in sport and
More informationThe Society for Patient Centered Orthopedics. Choosing Wisely List. James Rickert, MD 1
The Society for Patient Centered Orthopedics Choosing Wisely List James Rickert, MD 1 Extremities and Trauma Vertebroplasty Rotator Cuff Repair: For atraumatic (degenerative) tears in patients greater
More informationKnee Arthoscopy with or without Debridement Policy CRITERIA BASED ACCESS
Knee Arthoscopy with or without Debridement Policy CRITERIA BASED ACCESS Version: 1718.v2 Ratified by: Somerset CCG Clinical Commissioning Policy Forum (CCPF) Somerset CCG Clinical Operations Group (COG)
More informationHumber. Arthroscopy Knee
Humber Arthroscopy Knee Intervention Diagnostic & Therapeutic Arthroscopy Knee OPCS Codes W85 Therapeutic endoscopic operations on cavity of knee joint W851 Endoscopic removal of loose body from knee joint
More informationSubmission for The Knee. Title: Arthroscopic washout of the knee: A procedure in decline
Submission for The Knee Title: Arthroscopic washout of the knee: A procedure in decline Authors: Stefan Lazic 1, Oliver Boughton 1, Caroline Hing 1, Jason Bernard 1 1 St George s Hospital, Tooting, London,
More informationNordic Shoulder and Elbow Conference
8th Triennial Nordic Shoulder and Elbow Conference 16-17 May 2019 International faculty COURSE CHAIRMAN: Ilkka Sinisaari VENUE: Clarion Hotel, Helsinki, Tyynenmerenkatu 2, Helsinki PROGRAMME NORDIC SHOULDER
More informationEvaluation and Management of Knee Pain. Michael Cassat, MD University of Arkansas for Medical Sciences
Evaluation and Management of Knee Pain Michael Cassat, MD University of Arkansas for Medical Sciences Disclosure I have no actual or potential conflict of interest in relation to this program/presentation.
More informationKnee arthroscopic surgery is beneficial to middle-aged patients with meniscal symptoms: a prospective, randomised, single-blinded study
Knee arthroscopic surgery is beneficial to middle-aged patients with meniscal symptoms: a prospective, randomised, single-blinded study Håkan Gauffin, Sofi Tagesson, Andreas Meunier, Henrik Magnusson and
More informationAbatacept in B7-1 Positive Proteinuric Kidney Disease
correspondence practicing orthopedic surgeons, in which mechanical symptoms were not even included owing to the presumption that they would be unanimously considered a definite surgical indication. As
More informationTitle 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* Section/item Item No Description Addressed on page number Administrative information Title 1 Descriptive
More informationDegeneratiivne menisk
Degeneratiivne menisk Conflict of interest: none Microcirculation of the meniscus Age Dependent Inferior/Superior Geniculates Red zone peripheral 1/3 (3mm) Red/White zone Mid 1/3 (3-5mm) White zone Inner
More informationMethodological issues
Methodological issues in rehabilitation research Antti Malmivaara, MD, PhD, Chief Physician Centre for Health and Social Economics. National Institute for Health and Welfare Trusted evidence. Informed
More informationWORKPLACE SAFETY AND INSURANCE APPEALS TRIBUNAL DECISION NO. 615/15
WORKPLACE SAFETY AND INSURANCE APPEALS TRIBUNAL DECISION NO. 615/15 BEFORE: V. Marafioti : Vice-Chair B. Wheeler : Member Representative of Employers K. Hoskin : Member Representative of Workers HEARING:
More informationSurgical Threshold Policy
Surgical Threshold Policy KNEE ARTHROSCOPY FOR CHRONIC KNEE PAIN Definition This policy only covers the use of knee arthroscopy as a surgical intervention or diagnostic tool for chronic knee pain. It does
More informationArthroscopic Debridement of the Knee: OHTAC Recommendation
Arthroscopic Debridement of the Knee: OHTAC Recommendation Ontario Health Technology Advisory Committee November 2014 Arthroscopic Debridement of the Knee: OHTAC Recommendation. November 2014; pp. 1 12
More informationTable of Contents. 621 Lake Avenue, Unit 3A, Asbury Park, NJ Phone: Fax: gomohealth.com
Table of Contents 1.0 Cartilage Injury of the Knee Clinical Trial NCT03275064...2 1.1 Joint Cartilage Injury Information...4 1.1.1 Joint Cartilage Injury FAQs...6 1.1.2 Cartilage Injury of the Knee Study
More informationCONSORT 2010 checklist of information to include when reporting a randomised trial*
CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Title and abstract Introduction Background and objectives Item No Checklist item 1a Identification as a
More informationIncidental Meniscal Findings on Knee MRI
Transcript Details This is a transcript of an educational program accessible on the ReachMD network. Details about the program and additional media formats for the program are accessible by visiting: https://reachmd.com/programs/clinicians-roundtable/incidental-meniscal-findings-on-knee-mri/3772/
More informationCommonKnowledge. Pacific University. John Peixoto Pacific University. Alexandra Tarpo Pacific University. Recommended Citation.
Pacific University CommonKnowledge PT Critically Appraised Topics School of Physical Therapy 2012 Diagnostic Accuracy of the Thessaly Test for Predicting Meniscal Tears in Patients aged 15 to 50 as Measured
More informationSyddansk Universitet. Published in: Acta Orthopaedica (Print Edition) DOI: / Publication date: 2014
Syddansk Universitet Large increase in arthroscopic meniscus surgery in the middle-aged and older population in Denmark from 2000 to 2011 Thorlund, Jonas Bloch; Hare, Kristoffer Borbjerg; Lohmander, Stefan
More informationTitle:Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery
Author's response to reviews Title:Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery Authors: Eugen Lungu (eugen.lungu@umontreal.ca) François Desmeules
More informationNew Evidence Suggests that Work Related Knee Pain with Degenerative Complications May Not Require Surgery
4 th Quarter 2017 New Evidence Suggests that Work Related Knee Pain with Degenerative Complications May Not Require Surgery By: Michael Erdil MD, FACOEM Introduction It is estimated there are approximately
More informationOn Field Assessment and Management of Acute Knee Injuries: A Physiotherapist s Perspective
On Field Assessment and Management of Acute Knee Injuries: A Physiotherapist s Perspective Jessica Condliffe Physiotherapist / Clinic Manager TBI Health Wellington Presentation Outline Knee anatomy review
More informationDiagnostic validity of combining history elements and physical tests for traumatic and degenerative symptomatic meniscal tears
Diagnostic validity of combining history elements and physical tests for traumatic and degenerative symptomatic meniscal tears Décary S, Fallaha M, Pelletier B, Belzile S, Frémont P, Martel-Pelletier J,
More informationDECISION NO. 2870/16
Counsel: H.K., for Worker No one for Employer 2016 ONWSIAT 3235 Ontario Workplace Safety and Insurance Appeals Tribunal Decision No. 2870/16 2016 CarswellOnt 19003, 2016 ONWSIAT 3235 DECISION NO. 2870/16
More informationMeniscus Tears. Three bones meet to form your knee joint: your thighbone (femur), shinbone (tibia), and kneecap (patella).
Meniscus Tears Information on meniscus tears is also available in Spanish: Desgarros de los meniscus (topic.cfm?topic=a00470) and Portuguese: Rupturas do menisco (topic.cfm?topic=a00754). Meniscus tears
More informationEisuke Nomura, Hisatada Hiraoka, and Hiroya Sakai. 1. Introduction. 2. Case Report
Case Reports in Orthopedics Volume 2016, Article ID 1026861, 5 pages http://dx.doi.org/10.1155/2016/1026861 Case Report Spontaneous Recurrent Hemarthrosis of the Knee: A Report of Two Cases with a Source
More informationCRITICALLY APPRAISED PAPER (CAP)
CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION What are the observed effects on pain and fatigue when comparing two occupational therapy activity-pacing interventions in adults with osteoarthritis?
More informationCLINICAL PRESENTATION AND RADIOLOGY QUIZ QUESTION
Donald L. Renfrew, MD Radiology Associates of the Fox Valley, 333 N. Commercial Street, Suite 100, Neenah, WI 54956 12/01/2012 Radiology Quiz of the Week # 101 Page 1 CLINICAL PRESENTATION AND RADIOLOGY
More informationArthroscopic Lavage and Debridement for Osteoarthritis of the Knee
Ontario Health Technology Assessment Series 2005; Vol. 5, No. 12 Arthroscopic Lavage and Debridement for Osteoarthritis of the Knee An Evidence-Based Analysis September 2005 Medical Advisory Secretariat
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Dimitri Sirakoff 9/12/13 Department
More informationThe challenge of recruiting patients into a placebo-controlled surgical trial
Hare et al. Trials 2014, 15:167 TRIALS RESEARCH The challenge of recruiting patients into a placebo-controlled surgical trial Kristoffer B Hare 1,2*, L Stefan Lohmander 1,3 and Ewa M Roos 1 Open Access
More informationAppendix 2 Quality assessment tools. Cochrane risk of bias tool for RCTs. Support for judgment
Appendix 2 Quality assessment tools Cochrane risk of bias tool for RCTs Item Judgment (H/L/Unclear) Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants
More informationBest Care for patients with Knee pain
Best Care for patients with Knee pain 2016 Evidence shows that a supervised programme of physiotherapy should be the first line of treatment for patients with degenerative meniscal tears of the knee Kay
More informationMeniscus T2 Relaxation Time at Various Stages of Knee Joint Degeneration
Meniscus T2 Relaxation Time at Various Stages of Knee Joint Degeneration Richard Kijowski, Michael Fazio, Benjamin Beduhn, and Fang Liu Department of Radiology University of Wisconsin School of Medicine
More informationWhat is Medial Plica Syndrome?
What is Medial Plica Syndrome? It is a congenital disorder in which the thin wall of fibrous tissue extends from the synovial capsule of the knee. Pain usually occurs when the synovial capsule becomes
More informationI have nothing to disclose
Management of Common Knee Disorders: What You Knee d to Know UCSF Essentials of Women s Health July 8, 2015 Carlin Senter, M.D. I have nothing to disclose Learning objectives: in 1 hour you will be able
More informationPriorities Forum Statement GUIDANCE
Priorities Forum Statement Number 21 Subject Knee Arthroscopy including arthroscopic knee washouts Date of decision November 2016 Date refreshed March 2017 Date of review November 2018 Osteoarthritis of
More informationSystematic reviews and meta-analyses of observational studies (MOOSE): Checklist.
Systematic reviews and meta-analyses of observational studies (MOOSE): Checklist. MOOSE Checklist Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease:
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of partial replacement of the meniscus of the knee using a biodegradable scaffold
More informationWORKPLACE SAFETY AND INSURANCE APPEALS TRIBUNAL DECISION NO. 2023/14
WORKPLACE SAFETY AND INSURANCE APPEALS TRIBUNAL DECISION NO. 2023/14 BEFORE: A. T. Patterson: Vice-Chair HEARING: November 3, 2014 at Toronto Oral DATE OF DECISION: April 17, 2015 NEUTRAL CITATION: 2015
More informationChairman, Department of Sports Rehabilitation, Shanghai University of Sport
Author s response to reviews Title: Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial Authors:
More informationWORKPLACE SAFETY AND INSURANCE APPEALS TRIBUNAL DECISION NO. 611/16
WORKPLACE SAFETY AND INSURANCE APPEALS TRIBUNAL DECISION NO. 611/16 BEFORE: C. Sand : Vice-Chair M. Falcone : Member Representative of Employers F. Jackson : Member Representative of Workers HEARING: March
More informationRehabilitation Guidelines for Knee Arthroscopy
Rehabilitation Guidelines for Knee Arthroscopy The knee is the body's largest joint, and the place where the femur, tibia, and patella meet to form a hinge-like joint. These bones are supported by a large
More informationMedial Knee Osteoarthritis Precedes Medial Meniscal Posterior Root Tear with an Event of Painful Popping
Medial Knee Osteoarthritis Precedes Medial Meniscal Posterior Root Tear with an Event of Painful Popping Dhong Won Lee, M.D, Ji Nam Kim, M.D., Jin Goo Kim, M.D., Ph.D. KonKuk University Medical Center
More informationPDF of Trial CTRI Website URL -
Clinical Trial Details (PDF Generation Date :- Tue, 01 Jan 2019 02:42:38 GMT) CTRI Number CTRI/2008/091/000063 [Registered on: 08/07/2008] - Last Modified On Post Graduate Thesis Type of Trial Type of
More informationACR OA Guideline Development Process Knee and Hip
ACR OA Guideline Development Process Knee and Hip 1. Literature searching frame work Literature searches were developed based on the scenarios. A comprehensive search strategy was used to guide the process
More informationSUMMARY DECISION NO. 960/99. Tear (meniscus).
SUMMARY DECISION NO. 960/99 Tear (meniscus). The worker struck his knee on a metal stand in May 1996. The worker underwent surgery in November 1996 to repair a torn medial meniscus of the left knee. The
More informationArthroscopy of right knee icd 10 code
Buscar... Arthroscopy of right knee icd 10 code Free, official information about 2014 (and also 2015) ICD -9-CM diagnosis code V45.89, including coding notes, detailed descriptions, index cross-references
More informationGRADE. Grading of Recommendations Assessment, Development and Evaluation. British Association of Dermatologists April 2018
GRADE Grading of Recommendations Assessment, Development and Evaluation British Association of Dermatologists April 2018 Previous grading system Level of evidence Strength of recommendation Level of evidence
More informationPROSPERO International prospective register of systematic reviews
PROSPERO International prospective register of systematic reviews Closed reduction methods for acute anterior shoulder dislocation [Cochrane Protocol] Kanthan Theivendran, Raj Thakrar, Subodh Deshmukh,
More informationData Item Definition/Explanation
Please note: This document includes the definitions and explanation of the data items to be completed when submitting a clinical trial for registration on the ANZCTR. The information requested is based
More informationKnee Case Studies. You might KNEED to know some of this stuff
Knee Case Studies You might KNEED to know some of this stuff Mark Mildren, MD Specializing in Adult Reconstruction Slocum Center for Orthopedics & Sports Medicine 25 th Annual Orthopedic & Sports Medicine
More informationAnswer: To report this service use: Z Encounter for screening for other musculoskeletal disorders
Scoliosis Screening March 17, 2016 How do you report screening for scoliosis when the patient is sent by the school nurse or the pediatrician but, after the examination, there is no scoliosis identified?
More informationProtocol Development: The Guiding Light of Any Clinical Study
Protocol Development: The Guiding Light of Any Clinical Study Susan G. Fisher, Ph.D. Chair, Department of Clinical Sciences 1 Introduction Importance/ relevance/ gaps in knowledge Specific purpose of the
More informationRe-growth of an incomplete discoid lateral meniscus after arthroscopic partial resection in an 11 year-old boy: a case report
Bisicchia and Tudisco BMC Musculoskeletal Disorders 2013, 14:285 CASE REPORT Open Access Re-growth of an incomplete discoid lateral meniscus after arthroscopic partial resection in an 11 year-old boy:
More informationIs Meniscectomy such a bad thing compared to meniscal repair?
Is Meniscectomy such a bad thing compared to meniscal repair? Jack M. Bert, MD Adjunct Clinical Professor University of Minnesota Minnesota Bone & Joint Specialists, Ltd St. Paul, Minnesota Disclosures
More informationClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013. ClinicalTrials.gov ID: NCT
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013 ClinicalTrials.gov ID: NCT00168454 Study Identification Unique Protocol ID: 191622-077 Brief Title: A
More informationSecond Injury and Enhancement Fund [SIEF] (preexisting condition).
SUMMARY DECISION NO. 1423/97 Second Injury and Enhancement Fund [SIEF] (preexisting condition). The worker suffered a knee injury in March 1995. A torn meniscus was diagnosed and the worker underwent arthroscopic
More informationCOMMON KNEE AND SHOULDER INJURIES IN THE YOUNG ATHLETE. Outline 5/11/2017
COMMON KNEE AND SHOULDER INJURIES IN THE YOUNG ATHLETE IRVING RAPHAEL MD Syracuse Orthopedic Specialists Former S.U. Head Team Physician May 19, 2017 Meniscal Injuries anatomy Exam Treatment ACL Injuries
More informationFD FD: DT:D DN: 359/93 STY: PANEL: Strachan; Robillard; Jago DDATE: ACT: KEYW: Subsequent incidents (outside work); Significant contribution
FD FD: DT:D DN: 359/93 STY: PANEL: Strachan; Robillard; Jago DDATE: 250693 ACT: KEYW: Subsequent incidents (outside work); Significant contribution (of compensable accident to disability); Tear (meniscus);
More informationNIH NEW CLINICAL TRIAL REQUIREMENTS AND FORMS-E
NIH NEW CLINICAL TRIAL REQUIREMENTS AND FORMS-E HOW DOES THE NIH DEFINE CLINICAL TRIAL AND HOW DO I KNOW IF MY STUDY IS ONE? 01-18-18 A clinical trial is defined by the NIH as a research study in which
More informationCommon Knee Injuries
Common Knee Injuries In 2010, there were roughly 10.4 million patient visits to doctors' offices because of common knee injuries such as fractures, dislocations, sprains, and ligament tears. Knee injury
More informationCTRI Dataset and Description
CTRI Dataset and Description CTRI Field Description Public title of study Title intended for the lay public in easily understood language. Example: A clinical trial to study the effects of two drugs, ramipril
More informationunchanged; and the proportion with severe decreased from 7% to 4%; the proportion with mild pain decreased (48% to 32%;
Supplementary material to article by M. de Rooij et al. Course and predictors of pain and physical functioning in patients with hip osteoarthritis: Systematic review and meta-analysis and physical functioning
More informationClinialTrials.gov Identifier: Sponsor/company: sanofi-aventis
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov
More informationIcd 10 for lateral meniscus tear
Free, official coding info for 2018 ICD-10 -CM S83.282A - includes detailed rules, index and annotation crosswalks,. Short description: Other meniscus derangements, unsp medial meniscus, unsp knee; The
More information(Also known as a, Lateral Cartilage Tear,, Bucket Handle Tear of the Lateral Meniscus, Torn Cartilage)
Lateral Meniscus Tear (Also known as a, Lateral Cartilage Tear,, Bucket Handle Tear of the Lateral Meniscus, Torn Cartilage) What is a lateral meniscus tear? The knee joint comprises of the union of two
More informationSave the meniscus Mais pourquoi?
Save the meniscus Mais pourquoi? #$%&' ()"*+!," Philippe Neyret E Servien S Lustig P Verdonk One or more of the authors of the next presentation have identified no potential conflicts of interest 2 Consequences
More informationACL Athletic Career. ACL Rupture - Warning Features Intensive pain Immediate swelling Locking Feel a Pop Dead leg Cannot continue to play
FIMS Ambassador Tour to Eastern Europe, 2004 Belgrade, Serbia Montenegro Acute Knee Injuries - Controversies and Challenges Professor KM Chan OBE, JP President of FIMS Belgrade ACL Athletic Career ACL
More informationKNEE ARTHROSCOPY PATIENT INFORMATION SHEET
KNEE ARTHROSCOPY PATIENT INFORMATION SHEET Introduction It has been recommended that you undergo an arthroscopy of your knee. This information sheet is designed to explain what is involved in an arthroscopy,
More informationEvaluation and Treatment of Knee Arthritis Classification of Knee Arthritis Osteoarthritis Osteoarthritis Osteoarthritis of Knee
1 2 Evaluation and Treatment of Knee Arthritis John Zebrack, MD Reno Orthopaedic Clinic Classification of Knee Arthritis Non-inflammatory Osteoarthritis Primary Secondary Post-traumatic, dysplasia, neuropathic,
More informationMedical Practice for Sports Injuries and Disorders of the Knee
Sports-Related Injuries and Disorders Medical Practice for Sports Injuries and Disorders of the Knee JMAJ 48(1): 20 24, 2005 Hirotsugu MURATSU*, Masahiro KUROSAKA**, Tetsuji YAMAMOTO***, and Shinichi YOSHIDA****
More informationGuidelines for Reporting Non-Randomised Studies
Revised and edited by Renatus Ziegler B.C. Reeves a W. Gaus b a Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, Great Britain b Biometrie und Medizinische Dokumentation,
More informationHip Arthroscopy Criteria Based Access Protocol Supporting people in Dorset to lead healthier lives
NHS Dorset Clinical Commissioning Group Hip Arthroscopy Criteria Based Access Protocol Supporting people in Dorset to lead healthier lives 1. INTRODUCTION AND SCOPE NHS DORSET CLINICAL COMMISSIONING GROUP
More informationSMF PCP Treatment & Referral Guideline Orthopedics Developed February 1, 2003 Revised: October, 2011
SUTTER MEDICAL FOUNDATION (SMF) 2800 L Street, 7 th Floor Sacramento, CA 95816 SMF PCP Treatment & Referral Guideline Orthopedics Developed February 1, 2003 Revised: October, 2011 I. Shoulder Pain...Page
More informationTitle: Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives
Author s response to reviews Title: Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives Authors: Robert Beckett (rdbeckett@manchester.edu) Kathryn
More informationConservative surgical treatments for osteoarthritis: A Finite Element Study
Conservative surgical treatments for osteoarthritis: A Finite Element Study Diagarajen Carpanen, BEng (Hons), Franziska Reisse, BEng(Hons), Howard Hillstrom, PhD, Kevin Cheah, FRCS, Rob Walker, PhD, Rajshree
More informationFigure S2a- d. Written postoperative instructions given to patients in the APM- group after surgery, at OUH (S2a- b) and MHH (S2c- d).
Supplementary appendix Figure S1. Exercise therapy programme. Figure S2a- d. Written postoperative instructions given to patients in the APM- group after surgery, at OUH (S2a- b) and MHH (S2c- d). Figure
More informationTitle: Use of food labels by adolescents to make healthier choices on snacks: a cross sectional study from Sri Lanka
Author s response to reviews Title: Use of food labels by adolescents to make healthier choices on snacks: a cross sectional study from Sri Lanka Authors: Ishanka Talagala (drmaheshkeerthi@gmail.com;drishanka@gmail.com)
More informationFILED: KINGS COUNTY CLERK 04/23/ :08 PM INDEX NO /2016 NYSCEF DOC. NO. 29 RECEIVED NYSCEF: 04/23/2018
SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF KINGS ----------------------------------------------------------------X BETHZAIDA CARO, Plaintiff(s), -against- PHYSICIAN' PHYSICIAN'S AFFIRMATION Index
More informationMeniscal tear knee icd 10
synonyms: meniscal tear, meniscus tear. Meniscal Tear ICD-10. S83.202 (A,D,S)- Bucket-handle tear of unspecified knee S83.205 (A,D,S)- Other tear of unspecified meniscus, current injury, unspecified knee
More informationThis supplement contains the following items:
This supplement contains the following items: 1. Original protocol, final protocol, summary of changes 2. Original statistical analysis plan, final statistical analysis plan, summary of changes Original
More informationAuthor s response to reviews
Author s response to reviews Title: Evaluation of the Effectiveness of Music Therapy in Improving the Quality of Life of Palliative Care Patients: a Randomised Controlled Pilot and Feasibility Study Authors:
More informationProfessor Ewa Roos Center for Muscle and Joint Health Syddansk Universitet ewa_roos
Professor Ewa Roos Center for Muscle and Joint Health Syddansk Universitet eroos@health.sdu.dk ewa_roos Disclosures My salary and my department s budget is unaffected by my research results Developer of
More informationThe QUOROM Statement: revised recommendations for improving the quality of reports of systematic reviews
The QUOROM Statement: revised recommendations for improving the quality of reports of systematic reviews David Moher 1, Alessandro Liberati 2, Douglas G Altman 3, Jennifer Tetzlaff 1 for the QUOROM Group
More informationIncreasing incidence of rotator cuff repairs A nationwide registry study in Finland
Paloneva et al. BMC Musculoskeletal Disorders (2015) 16:189 DOI 10.1186/s12891-015-0639-6 RESEARCH ARTICLE Increasing incidence of rotator cuff repairs A nationwide registry study in Finland Juha Paloneva
More informationBackground: Traditional rehabilitation after total joint replacement aims to improve the muscle strength of lower limbs,
REVIEWING THE EFFECTIVENESS OF BALANCE TRAINING BEFORE AND AFTER TOTAL KNEE AND TOTAL HIP REPLACEMENT: PROTOCOL FOR A SYSTEMATIC RE- VIEW AND META-ANALYSIS Background: Traditional rehabilitation after
More informationKnee arthroscopy versus conservative management in patients with degenerative knee disease: a systematic review For peer review only
Knee arthroscopy versus conservative management in patients with degenerative knee disease: a systematic review Journal: BMJ Open Manuscript ID bmjopen-0-0 Article Type: Research Date Submitted by the
More information