Surgical Solutions innovative and comprehensive product line Metatarsophalangeal Joint Hallux Limitus Hallux Rigidus Lower Extremity Solutions
Hallux Limitus and Hallux Rigidus Hallux limitus is a progressive condition where the hallux, or big toe, has a limited or decreased range of dorsiflexion. If left untreated, pain and pressure placed on the joint while walking may cause arthritis, a dorsal bunion, and possible total loss of motion or hallux rigidus (the most severe stage of hallux limitus.) 1, 2 Hallux limitus may develop as a result of several contributing factors: Gradual deterioration of the joint due to age; poor footwear; obesity; a long elevated 1st metatarsal; trauma to the first metatarsal; rheumatoid arthritis; continuous cartilage wear and tear and/or fallen arches. Symptoms may result from a change in joint mechanics, or from an osteophyte or bunion formation particularly on the dorsal aspect of the metatarsal head. Pain or impingement of the dorsal osteophytes, inflammation, or shoe related pressure is also possible, along with motion pain from the articulating cartilage surface irregularity. 3, 4 Hallux rigidus symptoms develop in the last stage of hallux limitus. In addition to early stage symptoms, patients with hallux rigidus may also experience pain and stiffness in the big toe from degenerative arthritis and limited-to-absent range of motion. Degenerative arthritis is a type of wear and tear that causes a loss of cartilage in one or more joints and may change the way the foot functions. 1, 2, 3, 6 Pain is most associated with physical activities and may increase with running or jumping. Knee, hip, and/or lower back pain may develop as a result of a patient changing their stride to reduce pressure and discomfort. Common tests to evaluate hallux limitus and hallux rigidus are foot examinations, and the identification of bone spurs using diagnostic imaging. Radiographic findings could show flattening of the metatarsal head, narrowed joint space, location and size of bone spurs, as well as the degree of degeneration in the joint space. Range of motion is tested by bending the toe in an upward and then downward position to evaluate pain. 4, 7 Several grading levels or stages have been developed to describe and treat hallux limitus and hallux rigidus. Determining the treatment of each condition is based upon the grade or stage and health of the patient. If diagnosed and treated early, non-surgical methods such as limiting motion with a rocker type shoe, correct 4, 8, 9 shoe wear to eliminate pressure, orthotics, physical therapy, and/or cortisone shots may be an option. Surgeon Investigator Conservative Treatment Cheilectomy Coughlin 10 Grade 0, Grade I Grade I, Grade II, Grade III STAGING SYSTEMS Hanft Et Al 11 Grade I Hattrup + Johnson 12 Grade I Kravitz Et Al 13 Stage I Stage II Roukis 14 Stage I, Stage II Stage I, Stage II Keisermann 5 Stage I, Stage II, Stage III Stage I, Stage II, Stage III
Discussions on Staging Many staging systems for hallux limitus and hallux rigidus have been proposed, each with their own recommendations for procedures of diagnosis and treatment options. Because there is no universal agreement on a single staging system for the disease state, Integra LifeSciences Corporation has created this document to fairly and accurately represent a sample of the many staging systems available, in order to accommodate as many foot and ankle specialists as possible. The article, What s new in Foot and Ankle Surgery by Randall C. Marx, MD and Mark S. Mizel, MD, in the June 2009 issue of The Journal of Bone and Joint Surgery is effective in describing the current hallux limitus and hallux rigidus staging issue: Hallux rigidus is one of the most common causes of forefoot pain, yet a formal classification system has yet to be devised. Beeson et al. performed a review of the literature in order to determine if a gold standard classification system for hallux rigidus exists 27. Eighteen formal hallux rigidus classification systems that were based on radiographic appearance and/ or clinical findings were identified; however, different criteria and methods were used in their construction. Additionally, no classification systems had been rigorously tested for reliability or validity, and all were based mainly on clinical experience rather than formal research. That study underscores the need to develop a classification system based on properly constructed prospectively designed studies for a disease as common as hallux rigidus. 15 The staging systems contained herein were interpreted as accurately as possible from published literature from their respective investigators. All references used in the making of this document are available in the bibliography, on the back page. In cases where hallux limitus has significantly progressed, or in circumstances where non-surgical applications have failed, surgical treatment may be required to correct the damage. Integra LifeSciences Corporation offers innovative and comprehensive products, designed for the surgical procedures associated with the treatment of hallux limitus. Osteotomy Arthroplasty Arthrodesis Grade III, Grade IV Grade I, Grade II Grade III, Grade III B Grade III B Grade III Grade II Stage II, Stage III A, Stage III B Stage IV Stage IV Stage III Stage III, Stage IV Stage III Stage III 2
FEATURED SOLUTIONS Bold Compression Screw QWIX Fixation Screw Osteotomy Solutions The 1st metatarsal is cut to change the alignment of the bone in an attempt to correct the hallux limitus. Various osteotomies are performed for this clinical condition and Integra LifeSciences Corporation offers multiple solutions for them. Surgeon Investigator Osteotomy Coughlin 10 Hanft Et Al 11 Grade I, Grade II Hattrup + Johnson 12 Kravitz Et Al 13 Stage II, Stage III A, Stage III B Roukis 14 Stage III Keisermann 5 Stage III BOLD Compression Screw The BOLD Compression Screw is a totally intra-osseous implant with a large range of sizes and K-wire guided drilling and screwing. This self-tapping titanium alloy screw allows for true and controlled compression in forefoot osteotomies. The BOLD screw is indicated for fixation of bone fracture or for bone reconstruction including: - Fixation of small bone fragments, in long bones or small bone fractures - Arthrodesis in hand or foot surgery - Mono or Bi-Cortical osteomies in the hand or foot - Distal or proximal metatarsal or metacarpal osteotomies - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) QWIX Fixation Screw Sizes 3.0 & 4.3mm The QWIX Fixation Screws are designed to provide speed and precision for challenging surgical situations. This self-drilling, self-tapping QWIX 3.0 and 4.3 are designed with self-drilling flutes, but bone hardness can greatly vary by patient and anatomic area.* * The surgeon is responsible for assessing this hardness before using the self-drilling feature of the QWIX screws. Pre-drilling is advisable for dense or hard bone. Insertion features variable lags to ensure compression across the osteotomy site. The QWIX screw is indicated for fixation of bone fractures or for bone reconstruction including: - Fixation of small bone fragments, in long bones or small bone fractures - Mono or Bi-Cortical osteotomies in the hand or foot - Hallux Valgus treatment - Fractures management in the hand or foot - Arthrodesis in hand or foot surgery
FEATURED SOLUTIONS K2 Hemi Toe Implant System KGTI Kinetik Great Toe Implant System Arthroplasty Solutions Arthroplasties are surgeries that surgically repair a joint by replacing the articular surface with a new material, while removing the offending bone surface. Integra LifeSciences Corporation offers solutions for both partial and full arthroplasties of the first metatarsophalangeal joint. Surgeon Investigator Arthroplasty Coughlin 10 Hanft Et Al 11 Grade III A, Grade III B Hattrup + Johnson 12 Grade III Kravitz Et Al 13 Stage IV Roukis 14 Keisermann 5 Stage III K2 Hemi Toe Implant The K2 Hemi Toe Implant allows for minimal bone resection with full range of motion in the first metatarsophalangeal joint. This system is a metallic, one-piece surface replacement system and is inserted into the base of the proximal phalanx of the hallux. The K2 Hemi is indicated for use in patients suffering from pain and/ or loss of function due to: Osteoarthritis of the first metatarsophalangeal joint. Trauma involving the first metatarsophalangeal joint. Hallux rigidus with degenerative joint disease Hallux valgus associated with arthritis. KGTI Kinetik Great Toe Implant The KGTI system is designed for full anatomic range of motion with a precise fit using an optimal stem design. The system offers implants that are anatomically and biomechanically accurate, along with instrumentation that is simple and precise. The Kinetik Great Toe Implant is indicated for use in patients suffering from pain and/ or loss of function due to: Osteoarthritis of the first metatarsophalangeal joint. Rheumatoid arthritis with inflammatory joint disease. Trauma involving the first metatarsophalangeal joint. Hallux rigidus with degenerative joint disease Hallux valgus associated with arthritis. 4
FEATURED SOLUTIONS HALLU -Lock M.T.P. Arthrodesis System HALLU -Fix M.T.P. Arthrodesis System Arthrodesis Solutions The artificial fusion of two joints in cases of severe pain, often due to arthritis of the first metatarsophalangeal joint, is a commonly performed procedure with plates and screws. BOLD or QWIX screws are indicated for this application with two crossed screws as the common application. (See page 3 for product information.) Plates are featured below 16. Surgeon Investigator Osteotomy Coughlin 10 Grade III, Grade IV Hanft Et Al 11 Grade III B Hattrup + Johnson 12 Grade II Kravitz Et Al 13 Stage IV Roukis 14 Stage III, Stage IV Keisermann 5 HALLU -Fix MTP Arthrodesis HALLU-Fix is an anatomically adapted first MTP arthrodesis system that is not only versatile, but accurate and easily reproducible with the unique dual rotational axis (D.R.Ax) concept and a range of available sizes. Arthrodesis of the first metatarsophalangeal joint is recognized as a useful technique to treat such deformities as: - Hallux Rigidus - Severe hallux valgus (IM angle > 20 & HV angle > 40 ) - Deformity from rheumatoid arthritis - Traumatic arthritis HALLU -Lock MTP Arthrodesis with Surfix Locking Technology The HALLU-Lock system is one of Integra s most advanced product offerings. This system allows surgeons to take advantage of all the benefits of the HALLU-Fix system with the added benefit of state of the art locking screws. For use in fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint including: - Hallux Rigidus - Severe hallux valgus (IM angle > 20 & HV angle > 40 ) - Deformity from rheumatoid arthritis - Traumatic arthritis - Neuromuscular Instability - Failed previous surgical procedure
BOLD Compression Screw 3.0mm compression screw Cannulated Dual threaded for maximum compression Available in 10-34mm lengths QWIX Fixation Screw Self-drilling, self-tapping Cannulated 3.0 mm Diameter: Lengths 10mm - 34mm in 2mm increments 4.3 mm Diameter: Lengths 24mm - 40mm in 2mm increments and lengths 40mm - 60mm in 5mm increments HALLU-Fix M.T.P Arthrodesis System Plates are pre-bent contoured for optimal anatomical adaptation Snap-Off screw fixation Low profile 10 degrees of dorsal flexion and 10 degrees of valgus HALLU-Lock M.T.P Arthrodesis System with Surfix Technology Variable and Fixed Angle titanium Surfix screws Patented Surfix Locking Technology Contoured titanium plates 5 sizes of reamers for optimal adaptation K2 Hemi Toe Implant System Groove on plantar surface accommodates FHL tendon Anatomically designed implant matches the shape of the resected proximal phalanx Low profile implant minimizes bone resection Cobalt chrome with titanium plasma coated stem KGTI Kinetik Great Toe Implant System Two component system with instrumentation allowing for reproducible results Non-constrained implant allows for a full anatomic range of motion Optimal stem design improves implant stability Interchangeable components and complete range of sizes provide a precise fit 6
Surgical Solutions innovative and comprehensive product line Works Cited 1. Franson, Justin, and Babak Baravarian. Key Insights On Treating Hallux Limitus. Podiatry Today 1 Mar. 2007: 108-12. Podiatry Today. HMP Communications LLC. Web. 4 June 2009. <http://www.podiatrytoday.com>. 2. Hallux Rigidus and Hallux Limitus. OurHealthNetwork.com. N.p., 2006. Web. 09 June 2009. <http://www.ourhealthnetwork.com>. 3. Hollis, Minoo H. Hallux Rigidus. EMedicine - Medical Reference. WebMD, 14 Sept. 2007. Web. 09 June 2009. <http://www.emedicine.com>. 4. Roger, Mann A., Coughlin J. Michael, and DuVries L. Henri. Hallux Rigidus A Review of the Literature and a Method of Treatment. Clinical Orthopaedics and Related Research (n.d.): n. pag. Print. 5. Keiserman, Luciano S., V. James Sammarco, and G. James Sammarco. Surgical Treatment of Hallux Rigidus. Foot and Ankle Clinics 10 (2005): 75-96. 6. Stiff Big Toe (Hallux Rigidus). AAOS - Your Orthopaedic Connection. American Academy of Orthopaedic Surgeons, May 2002. Web. 09 June 2009. <http://orthoinfo.aaos.org>. 7. Coughlin, Michael J., and Paul S. Shurnas. Hallux Rigidus: Demographics, Etiology and Radiographic Assessment. Foot & Ankle International 24.10 (2003): 731-43. Print. 8. Coughlin, Michael J., and Paul J. Shurnas. Soft-Tissue arthroplasty for Hallux Rigidus. Foot & Ankle International 24.9 (2003): 661-72. Print. 9. Lam, Loan, Peter Blume, Michael Palladino, and Peter Blume. Departments: Lower Extremity Arthritis: What You Should Know About Hallux Limitus. Arthritis Practitioner. HMP Communications LLC, May 2007. Web. 09 June 2009. <http://www.arthritispractitioner.com>. 10. Coughlin, Michael J., and Paul S. Shurnas. Hallux Rigidus: Grading and Long-Term results of Operative Treatment. The Journal of Bone & Joint Surgery 85-A (2003): 2072-088. Print. 11. Hanft, J. R. et al (1993) A new radiographic classification system for hallux limitus. J. Foot Ankle Surg. 32 (4) 397-404. 12. Hattrup SJ, Johnson KA: Subjective results of hallux rigidus following treatment with chilectomy. Clin Orthop 226:182-91, 1988 13. Kravitz SR, LaPorta GA, Lawton JH. Progressive staging classification of hallux limitus and hallux rigidus. Lower Extremity 1: 55, 1994. 14. Roukis TS, Jacobs PM, Dawson DM, et al. A prospective comparison of clinical, radiographic and intraoperative features of hallux rigidus. J Foot Ankle Surg 41(2): 76-95, 2002. 15. Marx, Randall C., and Mark S. Mizel. What s New in Foot and Ankle Surgery. The Journal of Bone & Joint Surgery 91.6 (2009): 1023-031. Print. 16. Kelikian, Armen S. Technical Considerations in Hallux Metatarsalphalangeal Arthrodesis. Foot Ankle Clinics N America 10 (2005): 167-90. Print. Works Consulted Baravarian, Bob, and Jonathon Thompson. Metatarsal Head Resurfacing: Does it Have a Place in Treating Hallux Limitus/Rigidus? Podiatry Today Jan. 2008: 84-86. Print. Beresford, Sue. Hallux Limitus/Hallux Rigidus: An Evaluation and Critical Review of the Aetiology of HL/HR. Diss. University College Northampton, 2005. University College Northampton. Division of Podiatry. Web. 3 June 2009. <http://www.northampton.ac.uk>. Clinical Practice Guideline First Metatarsophalangeal Joint Disorders Panel. The Journal of Foot and Ankle Surgery 42.3 (2003): 112-54. Print. Coughlin, Michael J. Common causes of Pain in the Forefoot. The Journal of Bone & Joint Surgery (BR) 82-B.6 (2000): 781-90. Print. Coughlin, Michael J. Hallux Rigidus. The journal of Bone and Joint Surgery 85.A (2003): 2072-088. Print. Hallux Rigidus. Health Information and Advice Medicines Guide Patient.co.uk. N.p., n.d. Web. 09 June 2009. <http://www.patient.co.uk>. Hallux rigidus introduction. Hyperbook home. N.p., n.d. Web. 09 June 2009. <http://foothyperbook.com/elective/hr/halluxrigidusintro.htm>. Hallux Rigidus. Minneapolis Podiatrist, Footcare. N.p., n.d. Web. 09 June 2009. <http://www.footcareafa.com>. Hetherington, Vincent J. Textbook of Hallux Valgus and Forefoot Surgery. N.p.: n.p., n.d. Textbook of Hallux Valgus and Forefoot Surgery. Ohio College of Podiatric Medicine. Web. 2 June 2009. <http://www.ocpm.edu>. Schoenhaus, Harold. How to Select the Right Procedure for Hallux Limitus. Podiatry Today 1 Dec. 2003: 61-66. Print. The Stiff Big Toe Joint (Hallux Rigidus). The Institute for Foot&Ankle Reconstruction at Mercy. N.p., n.d. Web. 09 June 2009. <http://footandankle.mdmercy.com>. Wulker, Nikolaus. Hallux Rigidus. Turkshi Journal of Arthroplasty Arthroscopic Surgery 11.1 (2000): 95-103. Print. Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 877-444-1122 (USA) 609-936-5400 (Outside USA) 866-800-7742 (Fax) www.integra-ls.com Bold, HALLU, Newdeal, Surfix, and Qwix, are registered trademarks of Integra LifeSciences Corporation or its subsidiaries. K2, KGTI, and the Integra wave logo are trademarks of Integra LifeSciences Corporation or its subsidiaries. 2009 Integra LifeSciences Corporation. All rights reserved. Printed in the USA 500 ER3491-08/09