National Medical Policy Subject:

Unicondylar Interpositional Spacer

Policy Number:

NMP332

Effective Date*: March 2007 Updated:

March 2016

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Current Policy Statement Health Net, Inc. considers the unicondylar interpositional spacer not medically necessary due to lack of evidence in the peer review published literature to validate its long-term safety and effectiveness. Studies to date involve small numbers of patients and there lacks any long-term data. It is not known how this device compares with other treatments such as total or unicompartmental knee arthroplasty.

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.

ICD-9 Codes 715.16 715.26 715.96 715.96 716.16 716.26 716.36 716.56 716.66 716.86 716.96 719.46 719.56 V43.65

Osteoarthrosis, localized, primary, lower leg Osteoarthrosis, localized, secondary, lower leg Osteoarthrosis, localized, not specified whether primary or secondary, lower leg Osteoarthrosis, unspecified whether generalized or localized, lower leg Traumatic arthropathy, lower leg Allergic arthritis, lower leg Climacteric arthritis, lower leg Unspecified polyarthropathy or polyarthritis, lower leg Unspecified monoarthritis, lower leg Other specified arthropathy, lower leg Arthropathy unspecified, lower leg Pain in joint, lower leg Stiffness of joint, lower leg Joint replaced by other means, knee

ICD-10 Codes M12.861-M12.869 M12.9 M13.0 M13.161-M13.169 M13.861-M13.869 M15.561-M15.569 M17.10-M17.12 M17.5 M17.9 M25.561-M52.569 M25.661-M25.669

Other specific arthropathies, not elsewhere classified, knee Arthropathy, unspecified Polyarthritis, unspecified Monoarthritis, not elsewhere classified, knee Other specified arthritis, knee Traumatic arthropathy, knee Unilateral primary osteoarthritis of knee Other unilateral secondary osteoarthritis of knee Osteoarthritis of knee, unspecified Pain in knee Stiffness of knee, not elsewhere classified

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CPT Codes 27599

Unlisted procedure, femur or knee

HCPCS Codes N/A

Scientific Rationale – Update March 2015 There continues to be a paucity of peer reviewed medical literature to support unicondylar interpositional spacers for early stage osteoarthritis of the knee. Comparative studies and randomized controlled studies with this device and current treatments (i.e., total or unicompartmental knee arthroplasties) are necessary. Longterm data on patient outcomes are needed to determine the safety and efficacy of this device. There is no additional updated information from the American Academy of Orthopaedics on Osteoarthritis of the Knee 2 nd edition (2013), other than what is noted in the Scientific Rationale –Update March 2014. There are no Clinical Trials on unicondylar interpositional spacers.

Scientific Rationale – Update March 2014 Guidelines from the American Academy of Orthopaedics on Osteoarthritis of the Knee 2nd edition (2013) state that in the absence of reliable evidence, it is the opinion of the work group not to use the free-floating (un-fixed) interpositional device in patients with symptomatic medial compartment osteoarthritis of the knee. (Strength of Recommendation: Consensus) The guidelines note that the supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Per the AAOS guideline: “One published case series reported the results of free-floating (un-fixed) interpositional device surgery for treatment of medial unicompartmental OA of the knee. We determined that the evidence was low-strength. The evidence indicated high reoperation rates in the patients who were followed. Thirty-two percent of patients were revised to total knee arthroplasty. The evidence showed differences from baseline that were not clinically or statistically significant for increased pain measured with the VAS two years postoperatively. Knee Society Score function subscale scores were “poor” postoperatively. The AAOS workgroup modified the grade of this recommendation to consensus, because of the high revision rates in this study, increased pain, and the potential harm associated with this intervention (anesthesia risks, VTE, infection, and reoperation).” Peer review published literature is very limited. Seeger et al (2013) evaluated whether alignment correction can be achieved by UniSpacer arthroplasty as well as alignment change in the first 5 postoperative years is evaluated. Antero-posterior long leg stance radiographs of 15 legs were digitally analyzed to assess alignment Unicondylar Interpositional Spacer Mar 16

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change: two relevant angles and the deviation of the mechanical axis of the leg were analyzed before and after surgery. Additionally, the change of the postoperative alignment was determined one and five years postoperatively. Analyzing the mechanical tibiofemoral angle, a significant leg axis correction was achieved, with a mean valgus change of 4.7±1.9°; a varus change occurred in the first postoperative year, while there was no significant further change of alignment seen five years after surgery. Investigators concluded the UniSpacer corrects malalignment in patients with medial gonarthrosis; however, a likely postoperative change in alignment due to implant adaptation to the joint must be considered before implantation.

Scientific Rationale – Update April 2009 A December 2008 clinical practice guideline on the treatment of osteoarthritis (nonarthroplasty) from the American Academy of Orthopaedic Surgeons recommended against using a free-floating interpositional device for patients with symptomatic unicompartmental OA of the knee, based on the high revision rates and the potential harm associated with this intervention. A prospective study reported by Baile et al (2008) evaluated the clinical results of 18 patients treated with the Unispacer. The mean age of the patients was 49 years. A total of eight patients (44%) required revision within two years. In two patients revision to a larger spacer was required, and in six conversion to either a unicompartmental or total knee replacement was needed. At the most recent review 12 patients (66.7%) had a Unispacer remaining in situ. The mean modified visual analogue score for these patients at a mean follow-up of 19 months was 3.0. The mean pain level was 30% that of the mean pre-operative level of 10. The investigator concluded the Unispacer in isolated medial compartment osteoarthritis is associated with a high rate of revision surgery and provides unpredictable relief of pain.

Scientific Rationale Osteoarthritis (OA) is the most common form of arthritis in the United States. Also known as "wear and tear" arthritis, OA usually develops after many years of use and affects people who are middle aged or older. The prevalence and severity of osteoarthritis increase with age. Other risk factors for OA include obesity, injury to a joint and family history of osteoarthritis. This chronic disease causes the cushioning (cartilage) between the bone joints to wear away, leading to pain and stiffness. As the disease gets worse, the cartilage disappears and the bone rubs on bone. Patients with OA have pain that typically worsens with weight bearing and activity and improves with rest, as well as morning stiffness and gelling of the involved joint after periods of inactivity. On physical examination, patients often have tenderness on palpation – with/or without inflammation, bony enlargement, crepitus on motion, and/or limitation of joint motion. OA does not affect all joints equally and is most commonly found in the fingers, knee, hip, and spine, and rarely affects the elbow, wrist, and ankle. Although there is no known cure for OA, the goal of treatment is to reduce pain, maintain and/or improve joint mobility, and limit functional impairment. Treatment for OA includes analgesics such as acetaminophen or nonsteroidal anti-inflammatory medications (NSAIDs), activity modification including weight reduction, therapeutic exercise, modified footwear, orthoses, bracing, or ambulatory assistive devices. If these treatments fail to reduce or eliminate the pain, steroids injections into the joint may be used to decrease inflammation and the associated pain. Viscosupplemention,

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injection of an artificial joint fluid (e.g. Hyalgan [sodium hyaluronate], Synvisc [Hylan G-F 20], Supartz [highly purified sodium hyaluronate], Orthovisc [high molecular weight form of hyaluronic acid] or Euflexxa [an ultra-high purity hyaluronan]) may also be tried and may relieve pain for up to six months. There is some evidence that these supplements are helpful in controlling pain, although they do not appear to grow new cartilage. Surgical intervention may be indicated when pain, instability and function have not improved to a satisfactory level despite conservative treatment. Surgical options for OA of the knee include arthroscopy (e.g. knee debridement), osteotomy and joint replacement. The goal of surgery is to preserve or restore the articular cartilage surfaces. Patients with bi- or tricompartmental arthritis of the knee may require a total knee arthroplasty/replacement, however, for patients with unicompartmental arthritis surgical options also include tibial osteotomy or unicompartmental arthroplasty (UKA). Proposed advantages of UKA over total knee replacement (TKR) is providing more physiologic function, better range of movement, quicker recovery and the ability to convert the failed UKA into a TKR, delaying by up to a decade the TKR. During the 1970s and 1980s, orthopedic surgeons began developing and using UKA for treatment of unicompartmental osteoarthritis (OA) of the knee. Despite initial positive results from many groups, high failure rates increasingly were reported. Due to appropriate patient selection, refined surgical techniques and improved implant design, there has been a resurgence of interest in unicompartmental knee replacement as an alternative to both total knee replacement and osteotomy in the treatment of patients with unicompartmental, non-inflammatory arthritis. During the UKA, the rough edges of the end of the femur and top of the tibia are cut flat, cleaned, and then the unicompartmental device is cemented in place. As recommended by the American Academy of Orthopaedics, unicompartmental arthroplasty may be indicated in patients with unicompartmental arthritis of knee with unicompartmental pain that is unresponsive to conservative treatment. Per the recommendation, the patient should be 60 or older, not obese and relatively sedentary. Patients should have an intact anterior cruciate ligament (ACL), no significant inflammation and no damage to the other compartments, calcification of cartilage or dislocation. Contraindications to unicompartmental knee replacement include inflammatory arthritis, less than 90 degrees of flexion, greater than 15 degree flexion contracture, or a patient with a large deformity not amenable to correction with current unicompartmental designs. Unicondylar Interpositional Spacers (e.g. Orthoglide Medial Knee Implant, Advanced Bio-Surfaces, Inc; Unicondylar Interpositional Spacer (Unispacer), Sulzer Orthopedics, Inc/Centerpulse Orthopedics Inc; Knee Interpostional Mini-Repair System, Imaging Therapeutics, Inc.) are currently being investigated as a minimally invasive, bone preserving, approach for the treatment of the osteoarthritic knee. The spacer is a small kidney-shaped device which are geometrically designed to center itself and follow the normal motion of the knee. The metallic interpostional spacer fits between the natural bone structures of the knee and is not affixed with cement or screws. The device does not compromise future conversion to TKR as it does not require fixation or bone cuts. Per the FDA 510(k) summary, the Unicondylar Interpositional Spacer is intended for uncemented use in the treatment of moderate degeneration of the medial compartment of the knee (grade II-IV chondromalacia) with no more then minimal

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degeneration (grade I-II chondromalacia, no loss of joint space) in the lateral condyle and patellofemoral compartments in patients with osteoarthritis. The unispacer is proposed as an alternative to knee arthroplasty in patients who have failed less invasive treatment options (e.g. nonsteroidal anti-inflammatory drugs, viscosupplementation, and arthroscopic techniques) and still have significant pain and functional limitations. As a bridge procedure, this device is proposed for the younger, less active patient. Patients older than 65 years remain better candidates for conventional UKA and TKR because pain relief still remains a higher priority than bone and ligament preservation. This treatment allows for placement of the metallic spacer into the joint space above the affected medial tibial plateau. The femur then articulates against the polished, curved surface of the device. The unicondylar interpositional spacer is intended to be used without cement and is held in place by its geometry and the surrounding soft tissue structures. The UniSpacer is not suitable for patients with significant patellofemoral disease or significant lateral compartment disease, or those with subchondral bone loss. The anterior and posterior cruciate ligament structures must be intact. A technology assessment by the California Technology Assessment Forum (Tice, 2003) concluded that the UniSpacer did not meet CTAF’s assessment criteria. The assessment concluded “surgical placement of knee joint spacer devices requires evaluation in controlled trials in order to assess the efficacy and safety of the procedure before its widespread adoption can be advocated.” Sisto and Mitchell (2005) reported on a single surgeon experience with the UniSpacer for the treatment of medial compartment arthritis of the knee. Thirty-seven UniSpacer arthroplasties were performed in thirty-four patients, mean age of fiftyfive years (range, forty-two to seventy-five years) at the time of surgery. Twelve patients had had a previous arthroscopic meniscectomy. The mean preoperative Knee Society function score was 60 points (range, 40 to 80 points), and the mean preoperative Knee Society objective score was 62 points (range, 40 to 76 points). After a mean duration of follow-up of twenty-six months (range, twenty-four to twenty-nine months), there were no excellent, ten good, fifteen fair, and twelve poor results. The mean postoperative total function score was 69 points (range, 40 to 82 points), and the mean Knee Society objective score was 72 points (range, 45 to 88 points). Six of the twelve poor results were in knees that had dislocation of the UniSpacer. All twelve knees were revised to a total knee arthroplasty. Based on this experience, the author concluded that he could not recommend Unispacer arthroplasty. Conversley, Hallock and Fell (2003) reported that early results (one-and 2-year data) on 71 UniSpacer Knee System implants that were implanted in 67 patients suggest that an intra-articular metallic spacer is a viable treatment option for OA in the younger patient. Mean age and weight was 54 and 207 lb, respectively. All knees were evaluated using the Knee Society clinical rating system, Lysholm scoring scale, radiographic limb alignment, and ROM. The mean Knee Society knee score improved 169% in the 1-year group and 193% in the 2-year group. The mean Knee Society function score improved 31% and 65%, respectively. The mean Lysholm score improved 88% and 140%, respectively. Five implants (7%) were revised to total knee arthroplasty (TKA) and 10 implants (14%) were revised to another UniSpacer Knee System implant. Published medical literature are limited, and the long-term safety and efficacy of the UniSpacer has not yet been demonstrated. Studies to date involve small numbers of Unicondylar Interpositional Spacer Mar 16

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patients and there lacks any long-term data. It is not known how this device compares with other treatments such as total or unicompartmental knee arthroplasty. Further studies, with long-term data on patient outcomes, particularly in comparison with standard treatments, are necessary in order to determine safety and efficacy.

Review History March 2007 April 2008 April 2009 April 2010 April 2011 March 2012 March 2013 March 2014 March 2015 March 2016

Medical Advisory council, initial approval Update – no revisions Update – no revisions Update – no revisions Update. Added Medicare Table. No revisions Update – no revisions Update – no revisions. Code updates Update – no revisions Update - no revisions. Codes reviewed. Update – no revisions

This policy is based on the following evidence-based guidelines: 1. 2. 3. 4. 5. 6.

Tice JA. Knee Joint Spacer (UniSpacer) System for Osteoarthritis of the Knee. Technology Assessment. San Francisco, CA: California Technology Assessment Forum; February 13, 2003. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum 2000; 43:1905 American Academy of Orthopaedic Surgeons. AAOS clinical practice guideline on osteoarthritis of the knee. Rosemont (IL): American Academy of Orthopaedic Surgeons; 2003. American Academy of Orthopaedic Surgeons. AAOS clinical guideline on osteoarthritis of the knee (phase II). Rosemont (IL): American Academy of Orthopaedic Surgeons; 2003. American Academy of Orthopaedic Surgeons. Treatment of Osteoarthritis of the Knee. Clinical Practice Guideline. Dec 2008. Available at: http://www.aaos.org/research/guidelines/GuidelineOAKnee.asp American Academy of Orthopaedic Surgeons. Treatment of Osteoarthritis of the Knee. Evidenced based guideline. 2nd Edition. Summary of Reccommendations. May 2013: Available at: http://www.aaos.org/mwginternal/de5fs23hu73ds/progress?id=xMBz79btcCRpTXYll1Z4nE1hf4lTa2Inwt_jxO539s,

References – Update March 2016 1.

Sharma L. Osteoarthritis year in review 2015: clinical. Osteoarthritis Cartilage. 2016 Jan;24(1):36-48

References – Update March 2013 1.

Seeger JB, Cardenas-Montemayor E, Becker JF, et al. The UniSpacer: correcting varus malalignment in medial gonarthrosis. Preliminary results]. Rev Esp Cir Ortop Traumatol. 2013 Jan-Feb;57(1):15-20.

References – Update March 2012 1.

Köck FX, Beckmann J, Lechler P, et al. The 2-year follow-up results of a patientspecific interpositional knee implant. Orthopade. 2011 Dec;40(12):1103-10.

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References – Update April 2011 1.

ECRI. Custom Hotline Response. Unicondylar Interpositional Spacer Systems for Osteoarthritis of the Knee. July 2, 2009.

References – Update April 2010 1. 2.

Clarius M, Becker JF, Schmitt H, Seeger JB. The UniSpacer: correcting varus malalignment in medial gonarthrosis. Int Orthop. 2009 Nov 28. Richmond JC. Surgery for osteoarthritis of the knee. Med Clin North Am. 2009 Jan;93(1):213-22, xii.

References – Update April 2009 1.

Bailie AG, Lewis PL, Brumby SA, et al. The Unispacer knee implant: early clinical results Bone Joint Surg Br. 2008 Apr; 90(4): 446-50.

References 1. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) summary: Sulzer Orthopedics Unicondylar Interpositional Spacer. 2. Cepeda, M, Camargo, F, Zea, C, Valencia, L. Tramadol for osteoarthritis. Cochrane Database Syst Rev 2006; 3:CD005522 3. Bert JM. Unicompartmental Knee Replacement. Orthopedic Clinics of North America. 2005 Oct; 36(4):513-22 4. Hallock RH. The UniSpacer: a treatment alternative for the middle-aged patient. Orthop Clin North Am. 2005 Oct; 36(4):505-12. 5. Bjordal, JM, Ljunggren, AE, Klovning, A, Slordal, L. Non-steroidal antiinflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ 2004; 329:1317 6. Zhang, W, Jones, A, Doherty, M. Does paracetamol (acetaminophen) reduce the pain of osteoarthritis? A meta-analysis of randomised controlled trials. Ann Rheum Dis 2004; 63:901 7. Hallock RH, Fell BM. Unicompartmental tibial hemiarthroplasty: early results of the UniSpacer knee. Clin Orthop Relat Res. 2003 Nov;(416):154-63. 8. Marwin S. Trapp K. Medial Compartment Arthritis. Last updated April 2005. Available at: http://www.emedicine.com/orthoped/topic518.htm 9. Washington State Department of Labor and Industries. Review criteria for knee surgery. Provider Bull 2003 Dec;(PB 03-16):1-7. 10. Meek RM, Masri BA, Duncan CP. Minimally invasive unicompartmental knee replacement: rationale and correct indications. Orthop Clin North Am. 2004 Apr;35(2):191-200. 11. Mullican, WS, Lacy, JR. Tramadol/acetaminophen combination tablets and codeine/acetaminophen combination capsules for the management of chronic pain: a comparative trial. Clin Ther 2001; 23:1429 12. Rajasekhar C, Das S, Smith A. Unicompartmental knee arthroplasty. 2- to 12year results in a community hospital. J Bone Joint Surg Br. 2004 Sep;86(7):9835. 13. Sisto DJ, Mitchell IL. UniSpacer arthroplasty of the knee. J Bone Joint Surg Am. 2005 Aug;87(8):1706-11. 14. Scott RD. UniSpacer: insufficient data to support its widespread use. Clin Orthop Relat Res. 2003 Nov;(416):164-6. 15. Hallock RH. The UniSpacer Knee System: have we been there before? Orthopedics. 2003 Sep;26(9):953-4.

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16. Hochberg, MC, Altman, RD, Brandt, KD, et al. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. Arthritis Rheum 1995; 38:1541 Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective.

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