Background

Osteoarthritis (OA) affects approximately 21 million people in the United States.(1) By age 65 years, the majority of the population has radiographic evidence of OA, and 11% have symptomatic OA of the knee. The diagnosis of OA is established using a combination of clinical information derived from history, physical examination, radiologic imaging, and laboratory evaluation. An algorithm of diagnostic criteria for OA of the knee has been proposed by the American College of Rheumatology. The diagnosis of OA of the knee is defined as presenting with pain and meeting at least 5 of the following criteria:

• Patient older than 50 years of age
• Less than 30 minutes of morning stiffness
• Crepitus (noisy, grating sound) on active motion
• Bony tenderness
• Bony enlargement
• No palpable warmth of synovium
• Erythrocyte sedimentation rate less than 40 mm/h
• Rheumatoid factor less than 1:40
• Noninflammatory synovial fluid.

Treatment for OA of the knee aims to alleviate pain and improve function to mitigate reduction in activity. However, most treatments do not modify the natural history or progression of OA and thus are not considered curative. Nonsurgical modalities that are used include exercise; weight loss; various supportive devices; acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen; nutritional supplements (glucosamine and chondroitin); and intra-articular viscosupplements. Corticosteroid injection may be considered when relief from NSAIDs is insufficient or the patient is at risk from gastrointestinal adverse effects. If symptom relief is inadequate with conservative measures, invasive treatments may be considered. Operative treatments for symptomatic OA of the knee include arthroscopic lavage and cartilage debridement, osteotomy, and ultimately, total joint arthroplasty. Surgical procedures intended to repair or restore articular cartilage in the knee, eg, abrasion arthroplasty, microfracture techniques, and autologous chondrocyte implantation, are appropriate only for younger patients with focal cartilage defects secondary to injury and are not addressed in this policy.

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

I. Arthroscopic debridement and/or lavage are not considered medically necessary for the treatment of osteoarthritis of the knee except as noted below (see statement II).

(NOTE: Well-designed controlled trials provide sufficient evidence to conclude that arthroscopic debridement and lavage, separately or together, do not improve symptoms of osteoarthritis (OA) of the knee and, therefore, are not considered medically necessary. Guidelines from the American College of Orthopaedic Surgeons (AAOS) in 2013 provide a strong recommendation against performing arthroscopy with debridement or lavage in patients with a primary diagnosis of symptomatic osteoarthritis (OA) of the knee.)

· Arthroscopic lavage used alone for the osteoarthritic knee;
· Arthroscopic debridement for osteoarthritic patients presenting with knee pain only; or,
· Arthroscopic debridement and lavage with or without debridement for patients presenting with severe osteoarthritis (Severe osteoarthritis is defined in the Outerbridge classification scale, grades III and IV. Outerbridge is the most commonly used clinical scale that classifies the severity of joint degeneration of the knee by compartments and grades. Grade I is defined as softening or blistering of joint cartilage. Grade II is defined as fragmentation or fissuring in an area <1 cm. Grade III presents clinically with cartilage fragmentation or fissuring in an area >1 cm. Grade IV refers to cartilage erosion down to the bone. Grades III and IV are characteristic of severe osteoarthritis.)

· Operative notes,
· Reports of standing x-rays, or,
· Arthroscopy results.

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: This policy was created in 2009 and updated periodically with literature searches using the MEDLINE database. The most recent update was performed through March 15, 2018.

Arthroscopic debridement and lavage have been used extensively for the treatment of osteoarthritis (OA) of the knee. Because lavage and debridement are often performed at the same time, it is difficult to attribute the success or failure of arthroscopy to a specific procedure.(1)

Evidence of efficacy had for many years consisted of reports of case series or controlled trials with methodologic problems. In 2002, Moseley et al published a randomized placebo-controlled trial that found limited efficacy of arthroscopy for OA of the knee.(2) A total of 180 patients were randomly assigned to debridement (without abrasion or microfracture), lavage, or placebo surgery. Placebo surgery involved a skin incision and simulated debridement without insertion of the arthroscope. Patients and assessors were blinded to treatment group. Neither treatment group reported less pain or better function than the placebo group at any time point during the 2-year follow-up. A systematic review produced in 2007 for the Agency for Healthcare Research and Quality by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center noted that generalizability of these study results was limited by the lack of detail provided regarding the patient sample, use of a single surgeon, and enrollment of patients at a single Veterans Affairs Medical Center.(1) The report concluded that “the existing evidence does not definitively show that arthroscopic lavage with or without debridement is no more effective than placebo. However, additional placebo-controlled RCTs showing clinically significant advantage for arthroscopy would be necessary to refute the Moseley results, which show equivalence between placebo and arthroscopy.”

A 2008 Cochrane review of arthroscopic debridement for knee OA assessed 3 RCTs, including the study by Moseley et al and concluded that there is gold-level evidence that arthroscopic debridement has no benefit for undiscriminated OA (mechanical or inflammatory causes).(3) The other 2 studies included in the Cochrane review were of lower methodologic quality and compared arthroscopy with lavage. In one of the reviewed studies, Chang et al compared arthroscopy with closed needle lavage and found no significant between-group differences in pain, self-reported and observed functional status, and patient and physician global assessments.(4) This study was small (32 subjects) with only 3 months of follow-up. The second study was a randomized trial of 76 knees, 40 laparoscopic debridement and 36 washout, with mean follow-up time of 4.5 years and 4.3 years, respectively.(5) At 1 year, 32 of the debridement group and 5 of the washout group were pain-free. At 5 years, 19 of the survivors in the debridement group and 3 of the 26 in the washout group were free of pain. This study was noted by the Cochrane review to be at high risk of bias; specifically, outcome assessors were neither independent nor blinded, and pain was measured as success when absent and failure when present.

An updated systematic review of the evidence for joint lavage for OA of the knee was published by the Cochrane Musculoskeletal Group in May 2010 and was based on the literature to April 2009.(6) This review included 7 trials with 567 patients. The Cochrane review did not include the study described below by Kirkley et al,(7) since that trial focused on debridement. The authors concluded that joint lavage does not result in a benefit for patients with knee OA for pain relief or improvement in function.

In 2008, Kirkley et al(7) published a single-center randomized controlled trial comparing surgical lavage and/or arthroscopic debridement (without abrasion or microfracture) together with optimized physical and medical therapy, or physical and medical therapy alone. Patients with more than 5° of misalignment were excluded. Both men and women were enrolled. Seven experienced arthroscopists performed lavage, debridement, or both, at their discretion. Between January 1999 and August 2005, 277 patients were assessed for eligibility; 58 were not eligible (most [38%] because of substantial misalignment), and 31 declined participation. Ninety-two patients were randomly assigned to the surgery arm, and 86 were assigned to physical and medical therapy alone. Ten withdrew consent (2 in the surgery group and 8 in the control group). Six in the surgery group did not undergo surgery. Data from these patients were included in the intention-to-treat analysis. The primary outcome was total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included the SF-36 Physical Component Summary score. After 2 years, the mean (SD) WOMAC score for the surgery group was 874 (624), as compared with 897 (583) for the control group (absolute difference [surgery-group score minus control-group score], -23 [605]; 95% confidence interval [CI], -208 to 161; p=0.22). The SF-36 Physical Component Summary scores were 37.0 and 37.2, respectively (absolute difference, -0.2; 95% CI, -3.6 to 3.2; p=0.93). Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show superiority of surgery. Prespecified analyses of subgroups were performed for patients with less severe disease (Kellgren-Lawrence grade 2) at baseline and patients with mechanical symptoms of catching or locking, and no significant difference between treatment groups was found. A post hoc analysis of patients with more severe radiographic disease (Kellgren-Lawrence grade 3 or 4) also found no benefit of surgery.

A 2013 meta-analysis found no additional randomized trials on arthroscopic joint debridement for knee osteoarthritis.(8) Meta-analysis of studies with follow-up of 2 years or more found a conversion rate to joint replacement of 6.1% at 1 year, 16.8% at 2 years, 21.7% at 3 years, and 34.1% at 4 years. Data were not available on conversion to joint replacement in patients treated conservatively. This systematic review is limited by the inclusion of poor quality studies (level IV, uncontrolled and retrospective) and heterogeneity in study results. In addition, the definition of joint debridement in this meta-analysis included smoothing of cartilage lesions, removal of loose bodies, meniscectomy, synovectomy, and ligament release. The debridement could be combined with other types of treatment, including osteotomies or cartilage-restoring techniques (drilling, abrasion, microfracturing, and autologous chondrocyte implantation), making it difficult to isolate the specific impact of debridement on outcomes. Thus, interpretation of this meta-analysis is limited.

In an editorial, Marx comments that OA is not a contraindication to arthroscopic surgery and that it “remains appropriate in patients with arthritis in which osteoarthritis is not believed to be the primary cause of pain.”(9)

Clinical Input Received From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 2 physician specialty societies and 3 academic medical centers while this policy was under review for April 2009. The majority of the 5 reviewers providing input supported the conclusions of this policy that arthroscopic debridement and/or lavage are considered not medically necessary for treatment of osteoarthritis of the knee.

Summary

Arthroscopic lavage and cartilage debridement are operative treatments for osteoarthritis (OA) that may be performed separately or at the same time. The evidence base includes 2 large well-designed controlled trials, one comparing arthroscopic debridement with lavage and placebo, and the other comparing arthroscopy and lavage along with medical and physical therapy to medical and physical therapy alone. These studies provide sufficient evidence to conclude that arthroscopic debridement and lavage, separately or together, do not improve symptoms of OA of the knee and, therefore, are considered not medically necessary.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements
A systematic review of recommendations and guidelines for the management of OA was published in 2014 by the U.S. Bone and Joint Initiative. (10) Sixteen guidelines from the United States, Canada, Europe, and Asia were reviewed. Needle lavage and arthroscopy with débridement were not recommended for symptomatic knee OA by the American Academy of Orthopaedic Surgeons (AAOS; see next) or the U.K.’s National Collaborating Centre for Chronic Conditions. Osteoarthritis Research Society International (OARSI) guidelines from 2008 found limited support for these procedures. Overall, arthroscopy with débridement was not recommended.

Guidelines from the American Academy of Orthopaedic Surgeons (AAOS) in 2013 provide a strong recommendation against performing arthroscopic debridement and lavage: “We cannot recommend performing arthroscopy with lavage and/or debridement in patients with a primary diagnosis of symptomatic osteoarthritis of the knee.”(11) A strong recommendation means that the quality of the supporting evidence is high and that practitioners should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present. Based on moderate evidence, the AAOS “cannot suggest that the practitioner use needle lavage for patients with symptomatic osteoarthritis of the knee”.

In 2008, The Osteoarthritis Research Society International (OARSI) convened 16 experts from primary care, rheumatology, orthopedics, and evidence-based medicine from 6 countries, including the United States, to develop consensus recommendations for management of hip and knee OA. (12) OARSI concluded that “the roles of joint lavage and arthroscopic debridement are controversial and that, although some studies have demonstrated short-term symptom relief, others suggest that improvement in symptoms could be attributable to a placebo effect.”

U.S. Preventive Services Task Force Recommendations

Not applicable.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Arthroscopic Debridement and Lavage as Treatment for Osteoarthritis of the Knee
Debridement and Lavage as Treatment of Osteoarthritis of the Knee, Arthroscopic
Knee, Arthroscopic Debridement and Lavage as Treatment of Osteoarthritis
Lavage and Debridement as Treatment of Osteoarthritis of the Knee, Arthroscopic
Osteoarthritis of the Knee, Arthrosocpic Debridement and Lavage as Treatment
Treatment of Osteoarthritis of the Knee, Arthroscopic Lavage and Debridement

References:
1. Samson DJ, Grant MD, Ratko TA et al. Treatment of Primary and Secondary Osteoarthritis of the Knee. Evidence Report/Technology Assessment No. 157 (Prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). AHRQ Publication No. 07-E012. Rockville, MD: Agency for Healthcare Research and Quality. September 2007. Available online at: http://archive.ahrq.gov/clinic/tp/oakneetp.htm. Last accessed November, 2013.

2. Moseley JB, O'Malley K, Petersen NJ et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002; 347(2):81-8.

3. Laupattarakasem W, Laopaiboon M, Laupattarakasem P et al. Arthroscopic debridement for knee osteoarthritis. Cochrane Database Syst Rev 2008; (1):CD005118.

4. Chang RW, Falconer J, Stulberg SD et al. A randomized, controlled trial of arthroscopic surgery versus closed-needle joint lavage for patients with osteoarthritis of the knee. Arthritis Rheum 1993; 36(3):289-96.

5. Hubbard MJ. Articular debridement versus washout for degeneration of the medial femoral condyle. A five-year study. J Bone Joint Surg Br 1996; 78(2):217-9.

6. Reichenbach S, Rutjes AW, Nuesch E et al. Joint lavage for osteoarthritis of the knee. Cochrane Database Syst Rev 2010; (5):CD007320.

7. Kirkley A, Birmingham TB, Litchfield RB et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2008; 359(11):1097-107.

8. Spahn G, Hofmann GO, Klinger HM. The effects of arthroscopic joint debridement in the knee osteoarthritis: results of a meta-analysis. Knee Surg Sports Traumatol Arthrosc 2013; 21(7):1553-61.

9. Marx RG. Arthroscopic surgery for osteoarthritis of the knee? N Engl J Med 2008; 359(11):1169-70.

10. Nelson AE, Allen KD, Golightly YM, et al. A systematic review of recommendations and guidelines for the management of osteoarthritis: The Chronic Osteoarthritis Management Initiative of the U.S. Bone and Joint Initiative. Semin Arthritis Rheum. Jun 2014;43(6):701-712. PMID 24387819

11. Zhang W, Moskowitz RW, Nuki G et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008; 16(2):137-62.

12. American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee - 2nd edition. 2013. Available online at: http://www.aaos.org/research/guidelines/GuidelineOAKnee.asp. Last accessed November, 2013.

13. Mandl LA, Martin GM. Overview of surgical therapy of knee and hip osteoarthritis. In: UpToDate, Tugwell P, Curtiz MR (Eds), UpTODate, Waltham, MA. (Accessed on June 6, 2017.)

14. Mandl LA, Martin GM. Overview of surgical therapy of knee and hip osteoarthritis. In: UpToDate, Tugwell P, Curtiz MR (Eds), UpTODate, Waltham, MA. (Accessed on March 15, 2018.)

15. Mandl LA, Martin GM. Overview of surgical therapy of knee and hip osteoarthritis. In: UpToDate, Hunter D, Curtiz MR (Eds), UpTODate, Waltham, MA. (Accessed on May 3, 2019.)


Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

29871
29874
29877