What is the recommended approach for using orthobiologics, such as platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC), in the treatment of osteoarthritis?

Orthobiologics for Osteoarthritis: Evidence-Based Recommendations

Platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) are strongly recommended AGAINST for the treatment of knee and hip osteoarthritis, as current evidence does not support their use and significant concerns exist regarding lack of standardization and unproven efficacy. 1

Guideline-Based Position on Orthobiologics

The 2019 American College of Rheumatology/Arthritis Foundation guideline provides the most authoritative stance on orthobiologics in osteoarthritis management:

Strong Recommendations AGAINST Use

Platelet-Rich Plasma (PRP):

• Strongly recommended against for knee and hip OA due to heterogeneity and lack of standardization in available preparations, making it impossible to identify exactly what is being injected 1
• No recommendation made for hand OA due to absence of evaluation 1

Stem Cell Injections (including BMAC):

• Strongly recommended against for knee and hip OA due to heterogeneity, lack of standardization in preparations, and variable techniques 1
• No recommendation made for hand OA due to absence of evaluation 1

Critical Context from AAOS/NIH Consensus

The American Academy of Orthopaedic Surgeons 2018 consensus conference emphasized that clinical use of biologics has greatly outpaced the evidence, creating substantial patient vulnerability to unsubstantiated claims 1

Key terminology distinction: Minimally manipulated cell products should be referred to as "cell therapy" rather than "stem cells," and the untested and uncharacterized nature of these treatments must be clearly communicated to patients 1

Why These Recommendations Prioritize Patient Safety

Lack of Standardization

• No consistent preparation protocols exist across different PRP and BMAC formulations, making reproducibility impossible 1
• Injection techniques, concentrations, and cellular compositions vary dramatically between providers 1
• Without standardization, it is impossible to determine what specific product might benefit which patient 1

Insufficient Evidence for Efficacy

• Despite widespread marketing, high-quality evidence demonstrating meaningful improvement in morbidity, mortality, or quality of life is lacking 1
• The AAOS/NIH consensus identified knee OA as a "serious condition" requiring rigorous clinical trial development before orthobiologics can be recommended 1

Patient Vulnerability

• Direct-to-consumer marketing has created an environment where patients with chronic pain are vulnerable to unsubstantiated claims 1
• Professional organizations including the National Academy of Sciences and International Society for Cellular Therapy have issued calls to action regarding misinformation 1

Evidence-Based Treatment Algorithm for OA Instead

Start with proven core treatments that DO improve morbidity and quality of life:

First-Line (Strong Evidence)

• Regular supervised exercise programs including strengthening and low-impact aerobic exercise for at least 30 minutes most days 2, 3
• Weight loss of 5-10% body weight if overweight/obese through diet and exercise 2, 3
• Topical NSAIDs (e.g., diclofenac 2%) applied twice daily for knee OA 2, 3

Second-Line (Conditional Evidence)

• Oral NSAIDs at lowest effective dose for shortest duration, considering cardiovascular and gastrointestinal risks 2, 3
• Acetaminophen up to 3,000-4,000 mg/day for mild-to-moderate pain 2, 3
• Assistive devices such as cane in contralateral hand to reduce joint load 2, 3

Third-Line for Acute Flares

• Intra-articular corticosteroid injections for acute pain flares with joint effusion, limited to 3-4 per year 2, 3
• Benefits typically last up to 3 months 2

Surgical Consideration

• Total joint arthroplasty when severe symptoms persist despite optimal conservative management with bone-on-bone contact and significant deformity 2

Critical Pitfalls to Avoid

Do not substitute unproven orthobiologics for evidence-based treatments that have demonstrated benefits for morbidity and quality of life 4

Do not delay guideline-recommended therapies while pursuing orthobiologic treatments that lack sufficient evidence 4

If patients insist on orthobiologics despite recommendations:

• Clearly communicate the untested and uncharacterized nature of these treatments 1
• Explain lack of FDA approval and absence of standardization 1
• Document shared decision-making discussion regarding lack of evidence 1
• Ensure patients understand they are essentially participating in an uncontrolled experiment 1

Future Directions

The AAOS/NIH consensus recommends that any physician offering biologic therapies must commit to establishing high-quality patient registries and biorepository-linked registries for postmarket surveillance and quality assessments 1

Minimum standards for product characterization and clinical research must be followed before orthobiologics can be recommended for routine clinical use 1

High-quality multicenter randomized controlled trials with standardized preparations, validated outcome measures, and minimum 6-month follow-up are needed before any orthobiologic can be recommended 1