NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of inserting a biodegradable subacromial spacer for rotator cuff tears The rotator cuff is a group of muscles and tendons that surround the shoulder joint and help to keep it stable. A tear in or more of the rotator cuff tendons can cause pain and limit movement of the arm, and may lead to arthritis. When inserting a biodegradable subacromial spacer, a balloon-shaped device is implanted inside the shoulder joint. It creates a physical barrier between the bones (the acromion at the top of the joint and the humerus below). The aims are reducing pain, improving shoulder function and delaying more invasive surgery. The spacer dissolves after about year. Introduction The National Institute for Health and Care Excellence (NICE) has prepared this interventional procedure (IP) overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared This IP overview was prepared in September 205. Procedure name Inserting a biodegradable subacromial spacer for rotator cuff tears Specialist societies British Elbow & Shoulder Society (subgroup of the British Orthopaedic Association) IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page of 7
Description Indications and current treatment Patients with rotator cuff tears may have shoulder pain and weakness accompanied by functional limitation leading to a reduced quality of life. Rotator cuff tears can be caused by an injury or can develop gradually. They can be minor or severe depending on the degree of damage to the tendon. Minor tears to the rotator cuff are very common and may not cause any symptoms at all. Diagnosis is usually by ultrasound or MRI. Conservative treatment may include physical therapy, pharmacological treatments (including pain relief and topical or oral non-steroidal anti-inflammatory drugs) and corticosteroid injections. If the tear is severe or has not responded to other treatments, surgical interventions such as debridement, rotator cuff repair, subacromial smoothing, tendon transfer, or shoulder arthroplasty may be needed. What the procedure involves Inserting a biodegradable subacromial spacer aims to improve pain symptoms and restore shoulder function in patients who have irreparable rotator cuff tears. The intention is to reduce subacromial friction by lowering the humeral head during shoulder abduction. It aims to be a less invasive and potentially safer alternative to tendon transfer or shoulder arthroplasty, with shorter procedure and rehabilitation times. Inserting a biodegradable subacromial spacer is done with the patient under general or regional anaesthesia. The subacromial space is visualised using either arthroscopy or minimal access open surgery. A surgical clearance of the damaged area is carried out. Measurements are made to determine the required size of the biodegradable spacer. The balloon-like spacer is then inserted into the subacromial space and inflated with saline solution. Once sufficient volume is reached, the balloon is sealed and left in situ. The balloon spacer is made from a biodegradable polymer and resorbs over a period of about year. Literature review Rapid review of literature The medical literature was searched to identify studies and reviews relevant to inserting a biodegradable subacromial spacer for rotator cuff tears. The following databases were searched, covering the period from their start to 23 September 205: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 2 of 7
restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. The following selection criteria (table ) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. Table Inclusion criteria for identification of relevant studies Characteristic Publication type Patient Intervention/test Outcome Language Criteria Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patients with rotator cuff tears. Inserting a biodegradable subacromial spacer. Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. List of studies included in the IP overview This IP overview is based on 70 patients from 2 prospective case series. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 3 of 7
Table 2 Summary of key efficacy and safety findings on inserting a biodegradable subacromial spacer for rotator cuff tears Study Senekovic V (203) Details Study type Country Prospective case series Slovenia Recruitment period 2008 Study population and number Age and sex Patient selection criteria Technique Follow-up Conflict of interest/source of funding n=20 patients with massive irreparable rotator cuff tear Mean 70.5 years; 55% (/20) male Patients diagnosed with irreparable massive rotator cuff tear, persistent pain for at least 6 months with documented failure of conservative treatment and positive shoulder impingement test at screening. Exclusion criteria: significant shoulder osteoarthritis, prior shoulder surgery, shoulder infection or systemic immune suppression. All operations were performed with the patient in a beach chair position under general anaesthesia using 3 arthroscopic ports. Spacer size was selected based on surgeon s discretion following measurement of the distance between the lateral border of the acromion and the superior rim of the glenoid and after defining the extent of any tear extension. 3 years One or more of the authors received grants or outside funding from OrthoSpace Ltd. Also, a commercial entity (OrthoSpace Ltd.) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution or other charitable or non-profit organisation with which the authors are affiliated or associated. Analysis Follow-up issues: Prospective post-operative assessment of symptoms, complications or device-related adverse events was recorded with prospective determination of the Constant score at hospital discharge,, 3 and 6 weeks, 3, 6, 8 and 36 months after the procedure. Device placement and biodegradation were assessed by ultrasonographic evaluation at week and 3 and 6 months post-implantation. Device complete absorption and absence of significant device-related complications were confirmed by shoulder MRI at 3 years post-implantation. Three patients did not reach the 3-year follow-up: one patient withdrew consent 6 weeks post-implantation because of unsatisfactory outcome and referred to reverse total shoulder arthroplasty, the second patient had improvement in symptoms but refused to continue the participation in the study, and the third patient died during follow-up from cardiac disease not related to the implantation. Study design issues: Primary end points included pain relief over time, improvement in the range of motion, activities of daily living and shoulder strength using the Constant score. Patients were clinically assessed before the procedure for the presence of a full thickness massive rotator cuff tear (RCT) with supplementary imaging using ultrasound, CT arthrography and MRI as appropriate. Final confirmation of the RCT size, tendon involvement and reducibility was made during arthroscopy, in which the surgeon assessed the feasibility of surgical repair. Study population issues: All patients in this analysis had a >5 cm tear involving the supraspinatus and usually the infraspinatus with tissue quality validated at procedure as not adequate for repair (Goutallier grade 3 4). IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 4 of 7
The long head of biceps was found to be torn or ruptured in 3 patients. In the remaining 7 patients, a biceps tenotomy was done. Mean duration of symptoms before surgery was 34.7 months (range 4 95 months) with failure of conservative treatment in all patients. Other issues: There are some minor discrepancies in the paper between some of the numbers reported in the text and some of the numbers reported in the tables. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 5 of 7
Key efficacy and safety findings Efficacy Number of patients analysed: 20 Change in Constant score variables from pre-implantation up to 3 years after implantation (higher scores indicate improvement) Variable Total Constan t Score (TCS) Subjecti ve Pain Score Night pain Activity of Daily Living Range Of Motion Power Mean change from baseline to month 3 p value Mean change from baselin e to month 6 p value 9.83 0.0 5.92 <.000 3.2 0.65 2.8 4.52 0.000 5 <.000 0.002 5 0.08 3 3.67 <.000.0 <.000 3.65 5.73 Mean change from baselin e to month 8 0.000 6.49 0.002 3 p value 25.56 <.000 6.72 <.000 0.96 <.000 <.000 8.26 <.000 Mean change from baselin e to year 3 3.54 p value <.000 6.44 <.000.05 <.000 9.24 <.000 8. <.000 NA NA 3.0 0.0 4.5 0.003 7.9 <.000 Safety MRI at 3 years post-implantation of 2 patients who had no improvement in their total Constant score showed suspected synovitis without cystic formation. Authors state that statistically significant changes were evident in TCS assessment at the 6-week follow-up visit (95% CI 2.2 to 6.2; p=0.00), and this change continued to improve up to the final follow-up at 3 years with a mean change of 3.5 from baseline (95% CI 23.7 to 39.4; p<0.000). Authors also state that patients reported significant improvement in their activities of daily living beginning at the third week after surgery with continuous increase at 3 years of follow-up. The range of motion also showed significant improvement beginning at 6 weeks post-surgery and progressively increased throughout the study period. Shoulder power was difficult to evaluate early on in the post-implantation period but showed significant improvement at.5 years (95% CI 2. to 6.8; p=0.0003) which was sustained at 3 years (95% CI 4.7 to 9.6; p<0.000). In all measurable parameters, once an improvement reached significance, it was maintained throughout the follow-up period. Two patients had no improvement in their total Constant score, and MRI at 3 years post-implantation of these 2 patients showed suspected synovitis without cystic formation. Time for implantation: range 2 20 minutes Abbreviations used: CI, confidence interval; CT, computerised tomography; MRI, magnetic resonance imaging; NA, not applicable; RCT, rotator cuff tear; TCS, total Constant score. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 6 of 7
Study 2 Maman E (205) [conference abstract only] Details Study type Country Recruitment period Study population and number Age and sex Patient selection criteria Technique Follow-up Conflict of interest/source of funding Prospective case series Israel Not reported n=50 patients with massive rotator cuff tear Mean 69.7 years; 46% (23/50) male Patients with massive rotator cuff tear. Biodegradable sub-acromial spacer (InSpace) implantation. The biodegradable spacer was inserted arthroscopically or with a mini-open approach. Maximum year Not reported. Analysis Follow-up issues: Follow-up visits were scheduled according to routine clinical practice to assess safety and efficacy. 64% (32/50) of patients completed a minimum of 6 months follow-up and 46% (30/50) completed -year. Study design issues: 4 centres Shoulder function was evaluated using the total Constant score. Study population issues: Before implantation, 66% (33/50) of patients underwent debridement or arthroscopic subacromial decompression (ASD) and 33% (5/50) underwent ASD plus tenotomy of the long head of the biceps. Other issues: None. Key efficacy and safety findings Efficacy Number of patients analysed: 50 Efficacy findings from conference abstracts are not normally considered adequate to support decisions on efficacy and are not generally selected for presentation in the overview. Safety Device-related events: 4% (2/50) Displacement: /50 Deterioration in shoulder function: /50. The device was removed. Local inflammation/suspected aseptic synovitis: 6% (3/50) IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 7 of 7
Efficacy Improvement in shoulder function (assessed by the Constant score) A prospective case series of 20 patients with massive irreparable rotator cuff tear reported a significant increase in total Constant score (0 00, from worst to best outcomes) of 3.54 points 3 years after the procedure (p<0.000). No improvement in the total Constant score was reported in 0% (2/20) of patients; MRI of these 2 patients 3 years after implantation showed suspected synovitis without cystic formation. The prospective case series of 20 patients reported a significant increase in activity of daily living score (0 20, from worst to best) of 9.24 points 3 years after the procedure (p<0.000). The prospective case series of 20 patients reported a significant increase in range of motion score (0 40, from worst to best) of 8. points 3 years after the procedure (p<0.000). The prospective case series of 20 patients reported a significant increase in power score (0 25, from worst to best) of 7.9 points 3 years after the procedure (p<0.000). The prospective case series of 20 patients reported a significant increase in subjective pain score (0 5, from worst to best) of 6.44 points 3 years after the procedure (p<0.000). The prospective case series of 20 patients reported a significant increase in night pain score of.05 points (scale not given) 3 years after the procedure (p<0.000). Safety Local inflammation Suspected synovitis without cyst formation was reported in 2 patients 3 years after implantation (seen on MRI) in a prospective case series of 20 patients with massive irreparable rotator cuff tear (no further details given). Local inflammation/suspected aseptic synovitis were reported in 6% (3/50) of patients in a prospective case series of 50 patients with massive rotator cuff tear (no further details reported) 2. Deterioration in shoulder function IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 8 of 7
Deterioration in shoulder function was reported in patient in the prospective case series of 50 patients with massive rotator cuff tear; the device was removed (no further details reported) 2. Displacement of the device Displacement of the device was reported in patient in the prospective case series of 50 patients (no further details given) 2. Validity and generalisability of the studies The only case series of 20 patients with a follow-up of 3 years that was included for efficacy data only reported data on shoulder function improvement. One conference abstract about a case series of 50 patients with a -year follow-up was included for safety data. Existing assessments of this procedure A technology brief on InSpace biodegradable subacromial spacer for rotator cuff tears was published by the Australian Safety and Efficacy register of New Interventional Procedures Surgical (ASERNIP-S) in March 205. It states: Although positive results were reported in this assessment, the evidence-base supporting the use of the InSpace device is limited, as reflected in the current lack of Therapeutic Goods Administration (TGA) marketing approval. However, it is likely this device will have greater uptake in the private rather than the public hospital sector; therefore it is recommended that no further research on behalf of HealthPACT is warranted at this time. Related NICE guidance Below is a list of NICE guidance related to this procedure. Appendix B gives details of the recommendations made in each piece of guidance listed. Interventional procedures Shoulder resurfacing arthroplasty. NICE interventional procedure guidance 354 (200). Available from https://www.nice.org.uk/guidance/ipg354 IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 9 of 7
Extracorporeal shockwave lithotripsy for calcific tendonitis (tendinopathy) of the shoulder. NICE interventional procedure guidance 2 (2003). Available from https://www.nice.org.uk/guidance/ipg2 Specialist advisers opinions Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by Specialist Advisers, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, where comments are considered voluminous, or publication would be unlawful or inappropriate. Four Specialist Advisor Questionnaires for inserting a biodegradable subacromial spacer for rotator cuff tears were submitted and can be found on the NICE website. Patient commentators opinions NICE s Public Involvement Programme sent xxx questionnaires to xxx NHS trusts for distribution to patients who had the procedure (or their carers). NICE received 3 completed questionnaires. Section to be inserted if patient commentators raised no new issues The patient commentators views on the procedure were consistent with the published evidence and the opinions of the specialist advisers. Section to be inserted if patient commentators raised new issues The patient commentators raised the following issues about the safety/efficacy of the procedure, which did not feature in the published evidence or the opinions of specialist advisers, and which the Committee considered to be particularly relevant: [insert additional efficacy and safety issues raised by patient commentators and highlighted by IPAC, add extra rows as necessary]. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 0 of 7
[Last item in list]. Issues for consideration by IPAC Ongoing trials NCT02283 A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery. Study is recruiting. Spain. Estimated enrolment: 40 patients. Estimated completion date: December 207. NCT02208440 A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery. Study is recruiting. UK. Estimated enrolment: 40 patients. Estimated completion date: December 207. NCT022090 A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Efficacy and Safety of InSpace Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only in Subjects With a Full-thickness Large to Massive Rotator Cuff Tear. Study is recruiting. Israel. Estimated enrolment: 40 patients. Estimated completion date: December 207. NCT0890733 A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Efficacy and Safety of InSpace Device in Comparison to Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery. Study terminated. Italy. Enrolment: 5 patients. Estimated completion date: September 205. NCT02208453 A Single Arm, Open-label, Prospective, Study to Assess the Feasibility, Efficacy and Safety of InSpace Device Implantation in a Procedure Under Local Anesthesia for a Treatment of Subjects With Massive, IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page of 7
Irreparable Rotator Cuff Tear. Study recruiting. Italy. Estimated enrolment: 25 patients. Estimated completion date: August 207. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 2 of 7
References. Senekovic V, Poberaj B, Kovacic L et al. (203) Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. European journal of orthopaedic surgery & traumatologie 23:3-36. 2. Maman E, Adar E, Dekel A et al. (205) Biodegradable inflatable spacer as a novel treatment for massive rotator cuff tears: prospective multi-center study. International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine, ISAKOS congress 205 Lyon France. Conference publication eposter 2403. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 3 of 7
Appendix A: Additional papers on inserting a biodegradable subacromial spacer for rotator cuff tears There were no additional papers identified. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 4 of 7
Appendix B: Related NICE guidance for inserting a biodegradable subacromial spacer for rotator cuff tears Guidance Interventional procedures Recommendations Shoulder resurfacing arthroplasty. NICE interventional procedure guidance 354 (200) Current evidence on the safety and efficacy of shoulder resurfacing arthroplasty is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. Extracorporeal shockwave lithotripsy for calcific tendonitis (tendinopathy) of the shoulder. NICE interventional procedure guidance 2 (2003) Current evidence on the safety and efficacy of extracorporeal shockwave lithotripsy for calcific tendonitis of the shoulder appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance. IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 5 of 7
Appendix C: Literature search for inserting a biodegradable subacromial spacer for rotator cuff tears Databases Cochrane Database of Systematic Reviews CDSR (Cochrane) Date Version/files searched 23/09/205 Issue 9 of 2, September 205 HTA database (Cochrane) 23/09/205 Issue 3 of 4, July 205 Cochrane Central Register of 23/09/205 Issue 8 of 2, August 205 Controlled Trials (Cochrane) MEDLINE (Ovid) 22/09/205 946 to September week 2 205 MEDLINE In-Process (Ovid) 22/09/205 September 2, 205 EMBASE (Ovid) 22/09/205 974 to 205 week 38 PubMed BLIC (British Library) 23/09/205 n/a 23/09/205 n/a Trial sources searched on 22 09 205 Clinicaltrials.gov ISRCTN WHO International Clinical Trials Registry Websites searched on 22 09 205 National Institute for Health and Care Excellence (NICE) NHS England Food and Drug Administration (FDA) - MAUDE database Australian Safety and Efficacy Register of New Interventional Procedures Surgical (ASERNIP S) Australia and New Zealand Horizon Scanning Network (ANZHSN) EuroScan General internet search The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases.. Arthroplasty, Replacement/ or arthroplasty/ 2. (arthroplast* or arthroscop* or fluoroscop*).ti,ab. 3. video-assisted surgery/ 4. surgery, computer-assisted/ 5. ((minimall* or non) adj4 invasive* adj4 (surg* or procedure* or technique*)).ti,ab. 6. ((video* or comput*) adj4 (surg* or procedure* or technique*)).ti,ab. 7. or/-6 8. polymers/ IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 6 of 7
9. (copolymer* or co-polymer* or polymer* or biodegrad* or biograd* or saline* or fluid* or absorb*).ti,ab. 0. Joint Prosthesis/. absorbable implants/ 2. (implant* or space* or balloon*).ti,ab. 3. or/8-2 4. 7 and 3 5. Rotator Cuff/ 6. Shoulder Impingement Syndrome/ 7. Shoulder Joint/ 8. Shoulder Pain/ 9. Acromion/ 20. (shoulder* or rotat* or rotor* or rotar* or cuff* or humer* or abcromi* or subabcromi* or sub-abcromi* or acromion* or arthroscop* or supraspinatus* or infraspinatus* or "teres minor*" or teres-minor* or subscapularis*).ti,ab. 2. or/5-20 22. ((scar* or tear* or torn* or rip* or ruptur* or absenc* or irrepair* or irreparab* or imping* or fullthick* or full-thick* or non-funct* or nonfunct* or ruptur*) adj4 (lesion* or large* or partial* or massive* or tendon* or ligament* or muscle*)).ti,ab. 23. 2 and 22 24. 4 and 23 25. (Inspace or inspacetm or Orthospace).ti,ab. 26. 24 or 25 27. animals/ not humans/ 28. 26 not 27 IP overview: inserting a biodegradable subacromial spacer for rotator cuff tears Page 7 of 7