Is Monovisc (sodium hyaluronate) injection a viable treatment option for a patient with severe bilateral knee pain due to osteoarthritis, who has not responded to over-the-counter anti-inflammatory medications or previous injections?

Monovisc Injection for Bilateral Knee Osteoarthritis: Evidence-Based Assessment

Based on the highest quality and most recent guidelines, Monovisc (hyaluronic acid) injection should NOT be recommended for this patient, as major professional societies including the American College of Rheumatology (2019) and American Academy of Orthopaedic Surgeons (2022) conditionally recommend against viscosupplementation for knee osteoarthritis due to minimal clinical benefit, and this patient appears to be a candidate for surgical referral given severe refractory symptoms. 1, 2

Critical Guideline Recommendations Against Viscosupplementation

Major Society Positions

• The 2019 ACR/Arthritis Foundation guidelines conditionally recommend AGAINST intra-articular hyaluronic acid injections for knee osteoarthritis. 2 When limited to high-quality trials with low risk of bias, meta-analyses show the effect size of hyaluronic acid compared to saline approaches zero. 2

• The 2022 AAOS guidelines conditionally recommend AGAINST hyaluronic acid injections, citing limited efficacy with a number needed to treat of 17 patients. 1, 2

• The 2009 AAOS guidelines state they "cannot make a recommendation for or against" viscosupplementation due to concerns about trial quality, publication bias, and unclear clinical significance. 3 The guideline specifically notes that "pooled effects from poor-quality trials were as much as twice those obtained from higher quality ones." 3

• The 2008 NICE guidelines explicitly state that intra-articular hyaluronan injections are NOT recommended for the treatment of osteoarthritis. 3

Nuanced Evidence from EULAR

• The 2003 EULAR guidelines provide more favorable evidence for hyaluronic acid, noting pain reduction (Level 1B evidence) and functional improvement (Level 1B evidence). 3 However, they acknowledge that while pain relief may last several months versus weeks with steroids, this benefit is offset by slower onset of action and the requirement for 3-5 weekly injections with associated logistical and cost issues. 3

Why This Patient Should NOT Receive Monovisc

Patient Meets Criteria for Surgical Referral

This patient has multiple indicators for total knee arthroplasty consideration:

• Severe pain (7/10) with significant functional limitations affecting daily ambulation and activities. 1

• Failed conservative management including over-the-counter anti-inflammatory medications and previous injections. 1

• Radiographic evidence of moderate degenerative changes with medial compartment arthritis, varus alignment, and joint space narrowing. 1

• The AAOS recommends joint replacement for patients with refractory pain associated with disability when conservative management has failed. 1 Patients should be referred before there is prolonged and established functional limitation and severe pain. 3

Insurance Criteria Analysis

The insurance company's criteria require that the patient has failed:

• Non-pharmacologic treatments (physical therapy, exercise, bracing, weight reduction) - NOT documented in this case
• At least 3 months of analgesics/NSAIDs - only "over-the-counter" medications mentioned, duration unclear
• At least 3 months trial of intra-articular steroid injections - "previous injections" mentioned but type, timing, and adequate trial duration NOT documented

The documentation does NOT demonstrate that all conservative measures have been adequately attempted before considering viscosupplementation. 3, 1, 2

Appropriate Treatment Algorithm for This Patient

Immediate Considerations

1. Intra-articular Corticosteroid Injection (if not recently tried)

• The 2009 AAOS guidelines suggest intra-articular corticosteroids for short-term pain relief (Grade B recommendation). 3
• Evidence shows effectiveness at 1 week with clinically important pain reduction, though benefits are short-lived (1-3 weeks). 3
• The 2003 EULAR guidelines support steroid injection especially for pain flares with effusion (Level 1B evidence). 3
• This patient has a small effusion documented, making corticosteroid injection particularly appropriate. 3

2. Ensure Adequate Conservative Management Documentation

• Physical therapy with strengthening exercises and aerobic fitness training should be documented as attempted. 3, 2
• Weight loss if overweight or obese should be addressed. 3, 2
• Knee bracing for varus alignment should be considered. 3, 2
• Topical NSAIDs are recommended, particularly for older patients. 2
• Oral NSAIDs with appropriate gastroprotection should be optimized. 3, 2

3. Surgical Referral Evaluation

• This patient should be evaluated for total knee arthroplasty given severe bilateral pain (7/10), significant functional limitations, moderate radiographic changes, and failed conservative treatments. 1
• The AAOS and EULAR recommend referral before prolonged functional limitation becomes established. 3, 1
• Age should not be a barrier to surgical referral. 3

Common Pitfalls to Avoid

Documentation Failures

• Do not proceed with viscosupplementation without documenting adequate trials of first-line treatments. The insurance denial is appropriate given insufficient documentation of conservative management. 3, 1, 2

• "Previous injections" is inadequate documentation - specify type (steroid vs. hyaluronic acid), dates, duration of relief, and whether an adequate 3-month trial was completed. 3

Clinical Decision-Making Errors

• Do not use viscosupplementation as a substitute for surgical referral in appropriate candidates. This delays definitive treatment. 1

• Viscosupplementation should not be used for acute flares or effusions - corticosteroids are more appropriate. 3, 4

• The 2023 EUROVISCO consensus notes that severe radiographic osteoarthritis is a predictor of poor response to viscosupplementation. 4, 5 This patient has moderate degenerative changes approaching this threshold.

Contradictory Evidence Acknowledgment

While one 2019 RCT showed Monovisc provided statistically significant improvement over saline (p=0.043) with ≥50% pain reduction in some patients 6, and industry-supported consensus groups suggest viscosupplementation may be appropriate 4, 5, 7, the highest quality independent guidelines from AAOS, ACR, and NICE recommend against its use based on systematic reviews showing minimal clinically meaningful benefit when high-quality trials are analyzed. 3, 1, 2

Recommended Next Steps

1. Trial of intra-articular corticosteroid injection for short-term pain relief given documented effusion. 3

2. Optimize and document conservative management including physical therapy, bracing for varus alignment, weight management, and appropriate analgesics. 3, 2

3. Refer to orthopedic surgery for total knee arthroplasty evaluation given severity of symptoms, functional limitations, and radiographic evidence of moderate osteoarthritis. 3, 1

4. If patient refuses surgery or has contraindications to arthroplasty, then viscosupplementation could be considered as a last resort option, though expectations should be tempered given limited evidence of benefit. 1, 4, 5