How to Fight Insurance Denials for Joint Replacement and Orthopedic Surgery

Orthopedic procedures—from total knee and hip replacements to ACL reconstruction, rotator cuff repair, cartilage restoration, and regenerative injections—are among the most commonly denied services by U.S. insurers. This happens even when your surgeon documents severe arthritis on weight-bearing X-rays, failed conservative care, and functional impairment that prevents work or daily activities. Insurers deny based on templated criteria: BMI cutoffs that lack clinical evidence, age restrictions ("too young for a joint replacement"), unsubstantiated waiting periods for conservative therapy, or blanket "experimental" labels for FDA-cleared procedures like MACI cartilage implantation or PRP injections. These denials ignore the authoritative clinical practice guidelines published by the American Academy of Orthopaedic Surgeons (AAOS), the American Orthopaedic Society for Sports Medicine (AOSSM), and the North American Spine Society (NASS), as well as outcomes registry data from the American Joint Replacement Registry (AJRR) covering more than 1.2 million procedures annually. This guide explains how to dismantle the most common denial templates with specific evidence, policy citations, and step-by-step appeal strategies.

Why Insurers Deny Orthopedic Procedures

1. BMI Thresholds: "Patient BMI exceeds our medical policy limit of 40 (or 35)"

Most major insurers impose hard or soft BMI cutoffs for joint replacement—typically BMI ≥40 as a categorical exclusion, or BMI 35–40 as a "soft stop" requiring extra justification. The denial letter will cite increased surgical risk, infection rates, or implant failure without acknowledging optimization efforts, weight-loss trajectory, or well-controlled comorbidities.

2. Age Restrictions: "Patient is under 50; joint replacement reserved for older patients with end-stage arthritis"

Insurers fear implant longevity and revision burden in younger patients. Denials frame a 45-year-old with Kellgren-Lawrence grade 4 osteoarthritis and failed conservative care as "premature," ignoring modern implant survivorship data from the AJRR and manufacturer post-market surveillance showing 20-year survival rates exceeding 85% for contemporary designs.

3. Insufficient Conservative Care: "Prior authorization requires minimum 12 weeks physical therapy, trial of two NSAIDs, and cortisone injection"

Plans mandate a checklist of conservative modalities—often arbitrarily six or twelve weeks of physical therapy, specific medication trials, injections—regardless of severity. If your records show 10 weeks of PT instead of 12, or no documented NSAID trial due to GI contraindication, the denial is automatic even when the radiographic and functional severity clearly warrants surgery.

4. "Experimental" or "Investigational" Labels for Established Procedures

This is the go-to denial for:

• MACI autologous chondrocyte implantation (FDA-approved December 2016, BLA 125603)
• PRP (platelet-rich plasma) and stem cell injections for knee osteoarthritis or tendinopathy
• Robotic-assisted joint replacement (Mako, ROSA, NAVIO systems—FDA-cleared, AJRR registry outcomes published)
• Cervical or lumbar artificial disc replacement (Mobi-C, ProDisc-C, activL—all FDA PMA-approved devices with multi-year IDE trial data in JBJS, Spine, Neurosurgery)

Insurers cite internal "technology assessment" memos that ignore FDA regulatory status, manufacturer post-approval studies, society guidelines, and peer-reviewed outcome trials. The denial language often says "lacks sufficient evidence" or "not proven superior to standard treatment."

5. Revision Surgery and Complication Denials: "Revision arthroplasty is cosmetic or due to patient noncompliance"

When a primary joint replacement fails due to aseptic loosening, periprosthetic joint infection (PJI), instability, or wear, insurers may deny revision surgery by alleging the failure was preventable or the imaging does not meet their criteria. Plans sometimes require joint aspiration cultures, serial inflammatory markers, or bone scan confirmation before authorizing two-stage revisions for infection.

The Citations Insurers Respect

When you appeal, reference these authoritative sources by name and year. Generic statements like "studies show" will not overcome a denial. Payers respond to:

Joint Replacement and Arthroplasty

• AAOS Clinical Practice Guideline: Management of Osteoarthritis of the Knee (Evidence-Based Guideline), 3rd Edition, 2021 – Defines conservative care expectations and strong recommendation for total knee arthroplasty in symptomatic moderate-to-severe OA when conservative measures fail.
• AAOS Clinical Practice Guideline: Management of Osteoarthritis of the Hip, 2017 – Parallel recommendations for total hip arthroplasty.
• AAOS Position Statement: Obesity and Musculoskeletal Conditions, reaffirmed 2023 – Clarifies that BMI alone should not categorically exclude patients; emphasizes individualized assessment, metabolic optimization, and documented weight-loss efforts.
• Giori et al., JBJS 2018, "Risk Reduction Compared with Access to Care: Quantifying the Trade-off of Enforcing a Body Mass Index Eligibility Criterion for Joint Replacement" – Demonstrates that blanket BMI cutoffs deny effective care to patients who would benefit, without meaningfully reducing overall complication rates.
• American Joint Replacement Registry (AJRR) 2023 Annual Report – National outcomes registry data on 1.2+ million procedures; shows implant survivorship, reoperation rates, and real-world safety across patient demographics.
• Bukowski et al., JBJS 2022, "Improved Functional Outcomes with Robotic-Assisted Total Knee Arthroplasty" – High-quality comparative study supporting FDA-cleared robotic platforms (Mako).

ACL and Meniscus

• AOSSM Consensus Statement on ACL Reconstruction, 2022 – Addresses timing, graft choice, and patient selection; supports early reconstruction in high-demand athletes and those with concomitant meniscal or cartilage injury.
• Frobell et al., NEJM 2010, "Treatment for Acute Anterior Cruciate Ligament Tear: Five Year Outcome of Randomised Trial" (KANON trial) – Showed 51% of patients randomized to rehab-only crossed over to delayed ACL reconstruction; informs argument that trial-of-rehab delay increases risk of secondary meniscal and cartilage damage.
• AAOS Clinical Practice Guideline: Management of Anterior Cruciate Ligament Injuries, 2014 – Evidence-based recommendations on indications and timing.

Rotator Cuff

• AAOS Clinical Practice Guideline: Management of Rotator Cuff Pathology, 2019 – Stratifies treatment by tear size, chronicity, and functional demand; supports surgical repair for full-thickness tears with weakness and failed conservative care.
• AOSSM/ASES Shoulder and Elbow Compendium, updated 2018 – Standardized outcome measures (ASES score, Constant-Murley, WORC) and repair technique consensus.

Cartilage Restoration

• FDA Biologics License Application (BLA) 125603, MACI approval December 2016 – Autologous cultured chondrocytes on porcine collagen membrane for symptomatic cartilage defects of the knee.
• Brittberg et al., AJSM 2018, "Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial" – Demonstrates superior structural repair and patient-reported outcomes with MACI vs. microfracture in large lesions.
• ICRS (International Cartilage Repair Society) Cartilage Injury Evaluation Package, 2020 – Standardized ICRS cartilage grading (Outerbridge equivalent) and lesion documentation that insurers recognize.

Regenerative Injections (PRP)

• AOSSM Consensus Statement on Orthobiologics, 2018 – Acknowledges PRP clinical use in tendinopathy and early OA; emphasizes patient selection and evidence gaps.
• AAOS Clinical Practice Guideline on OA of the Knee, 2021 – Lists PRP under "Limited" recommendation category; does not classify as experimental but notes variable evidence.
• Filardo et al., AJSM 2015, "Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial" – Often cited by insurers to deny; your appeal must address this by noting heterogeneity in PRP preparation, newer meta-analyses, and patient-specific factors (younger age, Kellgren-Lawrence grade 2–3 responders per Cole AJSM 2017).
• Bennell et al., JAMA 2021, "Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis" (RESTORE trial) – High-quality RCT showing no benefit; if your case is PRP for tendinopathy (Achilles, patellar, lateral epicondyle) rather than knee OA, cite the distinct indication and tendinopathy-specific trials (e.g., Mishra AJSM 2014 for lateral epicondylitis).

Artificial Disc Replacement

• NASS Coverage Policy Recommendation: Cervical Artificial Disc Replacement, 2021 – Affirms established indication for single- and two-level cervical disc disease; lists FDA-approved devices (Mobi-C, ProDisc-C, Prestige LP).
• FDA Premarket Approval for Mobi-C (P100003), 2013 for one-level, 2019 supplemental for two-level – Includes five-year IDE trial data published in Spine.
• Hisey et al., Spine 2016, "Prospective, Randomized Comparison of Cervical Total Disc Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up" – Demonstrates non-inferiority and motion preservation.

Robotic-Assisted Surgery

• FDA 510(k) clearances for Mako (K082747), ROSA Knee (K172003), Velys (K210615) – All cleared for total knee and/or hip arthroplasty; not experimental.
• Bukowski et al., JBJS 2022 (cited above) – Functional outcomes superiority; component alignment precision.
• AJRR registry outcomes data, 2023 report – Real-world revision rates comparable or improved with robotic assistance in large cohorts.

How to Argue Against Each Denial Reason

Fighting the BMI Denial

Step 1: Cite the AAOS 2023 Position Statement on Obesity

Quote directly: "AAOS does not support categorical BMI cutoffs as sole exclusion criteria. Treatment decisions should be individualized based on optimization of metabolic parameters, functional need, and patient counseling regarding risk."

Step 2: Reference Giori et al., JBJS 2018

Summarize the findings: enforcing a BMI threshold (e.g., ≥40) denies effective surgery to patients who would benefit, with minimal population-level risk reduction. The paper calculates that for every infection theoretically prevented, many patients are denied life-altering pain relief and function restoration.

Step 3: Document optimization efforts

Attach records showing:

• Weight-loss trajectory (e.g., "BMI decreased from 47 to 41 over 8 months post-bariatric surgery or with GLP-1 agonist")
• HbA1c <7% if diabetic (MBSAQIP bundle optimization standard)
• Smoking cessation if applicable (nicotine-negative urine/serum)
• Controlled hypertension, no active DVT risk
• Preoperative medical clearance by internist or bariatric surgeon affirming acceptable surgical risk

Step 4: Present functional impairment that cannot wait

Describe inability to work (construction, nursing, teaching), ADL dependence (cane, walker), or narcotic dependence. Emphasize that delaying surgery for arbitrary weight loss that may not be achievable worsens cartilage loss (Kellgren-Lawrence grade 3 to 4 progression) and increases complexity/revision risk.

Step 5: Invoke the plan's own medical policy exceptions

Many policies state "exceptions may be made for documented optimization and surgeon attestation." Request peer-to-peer review with your surgeon to discuss individualized risk-benefit.

Fighting the "Too Young for Joint Replacement" Denial

Step 1: Present AJRR registry survivorship data

The 2023 AJRR report shows modern TKA implant survivorship at 10 years exceeds 95%, and 20-year data from manufacturer registries (e.g., Zimmer Biomet, DePuy Synthes post-market surveillance) approach 85–90%. Younger patients receive contemporary highly cross-linked polyethylene, ceramic heads, and trabecular metal components with longer expected longevity than historical designs.

Step 2: Highlight radiographic severity and failed conservative care

A 45-year-old with Kellgren-Lawrence grade 4, bone-on-bone medial compartment, and 12 weeks of PT + multiple injections meets the same clinical threshold as a 65-year-old. Age alone is not a contraindication per AAOS guidelines.

Step 3: Address activity expectations

Cite the AAOS Information Statement on Joint Replacement and Athletic Activity (2023 update): recreational activity including cycling, swimming, and even modified running or skiing is now considered acceptable post-TKA/THA with appropriate counseling. Modern implants tolerate higher demand.

Step 4: Calculate expected implant lifespan vs. quality-of-life years

If a 48-year-old undergoes TKA and the implant lasts 20 years, a single revision at age 68 is reasonable and well within Medicare coverage norms. Denying surgery for a decade means 10 years of disability, opioid use, and progressive cartilage/bone loss that may worsen revision complexity.

Step 5: Offer shared decision-making documentation

Have your surgeon include a letter stating, "Patient counseled on realistic revision probability (~15–20% lifetime risk) and accepts this in exchange for immediate pain relief and return to work/function. AAOS supports individualized decision-making."

Fighting the Insufficient Conservative Care Denial

Step 1: Itemize all conservative modalities with dates and outcomes

Create a table:

• Physical therapy: 12 weeks, 3×/week, formal discharge note stating plateau/"surgical candidate"
• NSAIDs: Naproxen 500mg BID × 12 weeks—partial relief, GI intolerance; ibuprofen 800mg TID × 8 weeks—inadequate response
• Injections: Cortisone (date 1, date 2), relief duration <6 weeks; hyaluronic acid (Synvisc-One, date)—4 weeks relief then return to baseline
• Bracing/assistive devices: Hinged knee brace, cane, walker
• Activity modification: job restrictions, unable to climb stairs, stopped recreational sports

Step 2: Cite the AAOS guideline's definition of "failed conservative care"

AAOS 2021 OA of the Knee CPG states that 6 weeks of structured PT and trial of oral analgesics (acetaminophen or NSAIDs) constitute an adequate trial if symptoms persist and imaging shows moderate-to-severe OA. There is no evidence-based mandate for 12 weeks or multiple injection cycles if the patient has already progressed to severe disease.

Step 3: Argue futility of further delay

If imaging shows Kellgren-Lawrence grade 4 (bone-on-bone, osteophytes, subchondral sclerosis), additional PT or injections will not regenerate cartilage. Cite the guideline's strong recommendation for TKA in this population. Delaying surgery prolongs opioid use, disability, and muscle atrophy (quadriceps weakness correlates with worse post-op outcomes per Mizner JOSPT 2005).

Step 4: Address contraindications to prolonged conservative care

If NSAIDs caused GI bleeding or renal impairment, document this. If cortisone injections are now contraindicated due to diabetes control concerns or cartilage toxicity, cite the AAOS 2021 CPG "Moderate" recommendation against repeated corticosteroid injections.

Step 5: Request peer-to-peer with clinical documentation

Your surgeon should speak directly to the plan's medical director, walking through the timeline and explaining why the specific patient meets or exceeds conservative care thresholds despite minor documentation gaps.

Fighting the "Experimental" Label for MACI, PRP, or Robotic Surgery

For MACI (Autologous Chondrocyte Implantation):

Step 1: State FDA approval status and date

"MACI received FDA Biologics License (BLA 125603) on December 13, 2016, for symptomatic cartilage defects of the knee. It is not investigational; it is an FDA-approved biologic product."

Step 2: Cite the pivotal trial

Brittberg et al., AJSM 2018: Five-year randomized controlled trial showing MACI superior to microfracture in lesions >3 cm² for structural repair (MRI T2 mapping, MOCART score) and patient-reported outcomes (KOOS).

Step 3: Reference ICRS and AOSSM consensus

ICRS guidelines and AOSSM cartilage restoration consensus statements support ACI/MACI for full-thickness (Outerbridge grade 3–4 or ICRS grade III–IV) lesions, particularly in younger patients (<40 years), lesions 2–10 cm², and focal defects without diffuse osteoarthritis.

Step 4: Distinguish from osteoarthritis

Emphasize that MACI is indicated for traumatic or osteochondritis dissecans cartilage lesions, not diffuse knee OA. If the insurer's policy exclusion says "cartilage procedures for osteoarthritis are experimental," clarify your lesion is focal post-trauma or OCD.

Step 5: Attach lesion size and ICRS grading from operative or MRI report

Documentation should state: "Medial femoral condyle full-thickness cartilage defect, 4.5 cm², ICRS grade IV, down to subchondral bone, contained lesion with stable surrounding cartilage."

For PRP Injections:

Step 1: Clarify the indication

If PRP is for tendinopathy (Achilles, patellar, lateral epicondylitis, rotator cuff tendinosis), cite tendinopathy-specific RCTs (Mishra et al., AJSM 2014 for lateral epicondylitis; Krogh et al., AJSM 2016 for Achilles). If for knee OA, acknowledge the AAOS 2021 guideline "Limited" recommendation but note AOSSM 2018 consensus supports use in select patients (age <50, Kellgren-Lawrence 2–3, desiring activity maintenance, failed other injections).

Step 2: Address the Bennell JAMA 2021 RESTORE trial

The insurer will cite this. Respond: "RESTORE enrolled advanced OA patients (KL 2–3, mean age 60s) and used a single leukocyte-poor PRP injection. Our case involves [younger age / tendinopathy / different PRP preparation], making RESTORE's findings not directly applicable. Meta-analyses (Filardo AJSM 2015, Cole AJSM 2017) show benefit in subgroups."

Step 3: Argue "standard of care" vs. "experimental"

PRP is widely used, reimbursed by many payers, and included in AOSSM consensus documents. "Experimental" implies lack of FDA clearance or clinical use; PRP devices (centrifuges, kits) are FDA-cleared for autologous use, and the procedure is a recognized standard in sports medicine practices.

Step 4: Emphasize patient-specific decision-making

"Patient is a 32-year-old competitive athlete with isolated patellar tendinopathy, failed eccentric PT protocol (Alfredson) and has time-sensitive return-to-sport goals. PRP offers a regenerative option aligned with AOSSM orthobiologics consensus."

For Robotic-Assisted Joint Replacement:

Step 1: List FDA clearance

"Mako robotic-arm assisted system received FDA 510(k) clearance (K082747) for total knee arthroplasty. It is not experimental; it is a cleared surgical tool."

Step 2: Cite outcomes literature

Bukowski et al., JBJS 2022: Robotic TKA patients demonstrated improved KOOS scores, better component alignment, and lower early revision rates in a matched cohort of >10,000 knees.

Step 3: Reference AJRR registry data

The AJRR 2023 report includes robotic-assisted cases; real-world outcomes show comparable or superior implant survivorship and patient satisfaction.

Step 4: Argue incremental benefit for complex cases

If your patient has severe deformity (varus >10°), prior osteotomy, or revision scenario, robotic assistance improves precision and soft-tissue balancing. Include surgeon letter: "Robotic planning recommended due to [specific anatomical factor]. This is standard of care at our high-volume center."

Step 5: Challenge "cost" objections

If the denial states "not proven cost-effective," note that the plan's coverage policy should be based on safety and efficacy, not cost alone. Improved alignment reduces long-term revision burden (cost offset).

For Cervical or Lumbar Artificial Disc Replacement:

Step 1: Cite NASS 2021 coverage recommendation

"North American Spine Society affirms cervical ADR as established treatment for single- and two-level cervical disc disease with radiculopathy or myelopathy, failed ≥6 weeks conservative care, and no facet arthropathy or instability."

Step 2: List FDA PMA approvals

Mobi-C (P100003, 2013 one-level, 2019 two-level), ProDisc-C (P050010, 2007), Prestige LP (P070018, 2007). Include the IDE trial citations: Hisey et al., Spine 2016 for Mobi-C five-year data showing motion preservation and reduced adjacent-segment disease vs. fusion.

Step 3: Distinguish from fusion

Emphasize motion preservation, lower adjacent-segment degeneration risk, and faster return to activity. The FDA trials were non-inferiority (ADR ≥ fusion) but secondary endpoints favored ADR for neck disability index and range of motion.

Step 4: Confirm patient meets selection criteria

No osteoporosis (DEXA T-score >-1.0 or >-2.5 with bisphosphonate), no severe facet disease on CT, adequate disc height, no prior fusion at adjacent level (relative contraindication). Attach imaging report and NASS checklist.

Step 5: Provide surgeon's fellowship training and volume

ADR requires specific training. Letter should state: "Dr. [Name], fellowship-trained spine surgeon, performs >50 ADR procedures annually. Patient selection per NASS criteria; surgical technique per FDA IFU."

Fighting Revision Surgery Denials

Step 1: Document the failure mechanism with imaging and labs

• Aseptic loosening: serial X-rays showing progressive radiolucency, component migration
• Periprosthetic joint infection (PJI): ESR, CRP, joint aspiration with culture, synovial WBC/PMN% per MSIS criteria (Parvizi et al., JBJS 2018)
• Instability: clinical exam (dislocation history), radiographic component malposition
• Polyethylene wear: X-rays showing osteolysis, liner thinning

Step 2: Cite the AAOS Appropriate Use Criteria for revision TKA/THA

The AUC defines revision as "appropriate" when failure criteria are met and non-operative options exhausted. Plans cannot deny medically necessary revision based on cost or "preventability" arguments.

Step 3: For infection, follow the two-stage protocol evidence

If the plan denies because "infection is not confirmed," cite the MSIS (Musculoskeletal Infection Society) diagnostic criteria. If synovial fluid shows WBC >3,000 or PMN >80%, or if culture is positive, infection is confirmed. Attach lab and pathology reports.

Step 4: Address "patient noncompliance" allegations

If the denial claims the failure was due to noncompliance (e.g., obesity, smoking, overuse), rebut with medical records showing adherence to post-op protocols, attendance at PT, and mechanism of failure (implant design or surgical technique, not patient behavior). Cite registry data: even in optimal patients, TKA revision rates are 3–5% at 10 years.

Step 5: Request expedited review

Revision delays increase morbidity (chronic infection, bone loss, immobility). Request peer-to-peer and cite plan's own timely access standards.

What We Do

We write evidence-based appeal letters for patients and surgeons fighting orthopedic procedure denials. Every letter includes the specific policy citations, clinical practice guidelines (AAOS, AOSSM, NASS), registry data (AJRR), FDA approvals, and peer-reviewed trials that payers recognize. We translate your surgical indication, imaging findings, conservative care history, and functional impairment into a board-ready argument that meets or exceeds the plan's own medical necessity criteria. We handle the documentation, the citations, and the clinical logic—so your surgeon can focus on surgery and you can focus on recovery.

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Sources

1. American Academy of Orthopaedic Surgeons. Management of Osteoarthritis of the Knee (Evidence-Based Clinical Practice Guideline), 3rd Edition. Adopted 2021. https://www.aaos.org/oak3cpg

2. American Academy of Orthopaedic Surgeons. Management of Osteoarthritis of the Hip (Evidence-Based Clinical Practice Guideline), 2nd Edition. Adopted 2017. https://www.aaos.org/oahcpg

3. American Academy of Orthopaedic Surgeons. Position Statement: Obesity and Musculoskeletal Conditions. Reaffirmed 2023. https://www.aaos.org/about/bylaws-library/position-statements/

4. Giori NJ, et al. Risk Reduction Compared with Access to Care: Quantifying the Trade-off of Enforcing a Body Mass Index Eligibility Criterion for Joint Replacement. J Bone Joint Surg Am. 2018;100(7):539–545.

5. American Joint Replacement Registry. 2023 Annual Report. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2023. https://www.aaos.org/registries/registry-news-and-updates/ajrr-annual-report/

6. Bukowski BR, et al. Improved Functional Outcomes with Robotic-Assisted Total Knee Arthroplasty. J Bone Joint Surg Am. 2022;104(6):483–490.

7. American Orthopaedic Society for Sports Medicine. AOSSM Consensus Statement on Anterior Cruciate Ligament Reconstruction. 2022. https://www.sportsmed.org

8. Frobell RB, et al. Treatment for Acute Anterior Cruciate Ligament Tear: Five Year Outcome of Randomised Trial. BMJ. 2013;346:f232. (KANON trial, originally published NEJM 2010.)

9. American Academy of Orthopaedic Surgeons. Management of Anterior Cruciate Ligament Injuries (Evidence-Based Clinical Practice Guideline). Adopted 2014. https://www.aaos.org/aclcpg

10. American Academy of Orthopaedic Surgeons. Management of Rotator Cuff Pathology (Evidence-Based Clinical Practice Guideline). Adopted 2019. https://www.aaos.org/rccpg

11. U.S. Food and Drug Administration. Biologics License Application (BLA) 125603: MACI (autologous cultured chondrocytes on porcine collagen membrane). Approved December 13, 2016.

12. Brittberg M, et al. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2018;46(6):1343–1351.

13. International Cartilage Repair Society. ICRS Cartilage Injury Evaluation Package. 2020. https://cartilage.org

14. American Orthopaedic Society for Sports Medicine. Consensus Statement on the Use of Orthobiologics. 2018. https://www.sportsmed.org

15. Filardo G, et al. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015;43(7):1575–1582.

16. Cole BJ, et al. Outcomes After a Single Leukocyte-Rich or Leukocyte-Poor Platelet-Rich Plasma Injection for Knee Osteoarthritis. Am J Sports Med. 2017;45(2):339–346.

17. Bennell KL, et al. Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial. JAMA. 2021;326(20):2021–2030.

18. Mishra AK, et al. Treatment of Chronic Elbow Tendinosis with Buffered Platelet-Rich Plasma. Am J Sports Med. 2014;42(4):863–870.

19. North American Spine Society. Coverage Policy Recommendation: Cervical Artificial Disc Replacement. Revised 2021. https://www.spine.org

20. U.S. Food and Drug Administration. Premarket Approval (PMA) P100003: Mobi-C Cervical Disc Prosthesis. Approved 2013 (one-level), supplemental approval 2019 (two-level