BioPoly implant for knee cartilage defects

Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly® Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur

This study is testing a new knee implant to see if it can help adults with cartilage damage feel better and avoid more surgery compared to standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: BioPoly LLC (Industry-sponsored)
• Locations: 1 site (Fort Wayne, Indiana)
• Trial ID: NCT06915363 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for treating cartilage defects in the knee. It involves a randomized controlled design where participants are assigned to receive either the BioPoly implant or the standard care treatments, such as microfracture or debridement. The primary goal is to assess the composite clinical success at 24 months, focusing on improvements in knee function and the need for further surgical interventions. Eligible participants are adults aged 30 to 65 with specific cartilage lesions that have not responded to conservative treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 65 with symptomatic cartilage lesions in the knee that have failed previous non-surgical treatments.

Not a fit: Patients with cartilage lesions that do not meet the specified criteria or those who are not candidates for surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief from knee pain and improve function for patients with cartilage defects.

How similar studies have performed: Other studies have shown promise with similar surgical interventions for cartilage defects, suggesting potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Patient is between 30 and 65 years of age25.
2. KOOS quality of life score ≤ 60.
3. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the Post-Operative rehabilitation and follow-up protocol.
4. Patient has cartilage lesion that has failed non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) after at least 2 months of beginning the therapy or failed surgical conservative therapy (e.g. debridement/lavage, marrow stimulation, or alignment high tibial osteotomy) that was performed at least 12 months ago in the index knee and is a candidate for surgical intervention.
5. Patient has cartilage lesion located in the femoral condyle or trochlear facet.
6. Patient has lesion(s) classified as ICRS grade 2, 3 or 4.
7. Patient's lesion size may not exceed 3.1 cm2 and must be circumscribed by a 1.5 cm or 2.0 cm diameter circle, or 1.5 cm (M-L) by 2.4 cm (A-P) oval of normal or nearly normal (ICRS grade 0 or 1) cartilage, with an overall depth less than 4mm from the articulating surface.
8. Patient has subchondral bone quality that is non-osteoporotic and is sufficient to support the implant. The quality of bone will be assessed by the surgeon intraoperatively with a surgical instrument such as an awl.

Exclusion Criteria:

1. Patient has body mass index (BMI) ≥ 35.
2. Patient has autoimmune arthritis, as diagnosed by Investigator.
3. Patient has advanced degenerative osteoarthritis in index knee (Kellgren-Lawrence Grade 4 and/or diagnosed intraoperatively).
4. Contralateral knee is known to have symptomatic cartilage, meniscal, or ligamentous lesions, generalized osteoarthritis, or requires surgery.
5. Patient has gout, by Investigator diagnosis or patient-reported history within last 12 months.
6. Patient has a cartilage lesion that is being treated with a non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) and it has been \< 2 months since beginning treatment or the patient's cartilage lesion has failed surgical therapy (e.g. debridement/lavage, marrow stimulation, alignment (high tibial osteotomy)) in the index knee and it has been \< 12 months since the surgical treatment.
7. Patient has a cartilage lesion that is being treated that has failed ACI, OATS or Allograft treatment.
8. Patient has malalignment of the index knee (\>5 degrees weight bearing varus or valgus).
9. Patient has bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e. greater than ICRS Grade 2 on the opposing articular surface) in the index knee.
10. Patient has uncorrected ligamentous instability (good joint stability in the index joint with a Grade 1 Lachman or less, no pivot shift for ACL insufficiency and no posterior translation of more than grade 1; no deficits in flexion or extension of \> 10 degrees compared to contralateral knee) in the index knee.
11. Patient has undergone a total meniscectomy of index knee.
12. Patient has undergone patellofemoral arthroplasty of the index knee
13. Patient currently reports or has a documented history of uncontrolled diabetes.
14. Patient currently has any condition, therapy, or medication known to impair bone healing.
15. Patient has had an active systemic infection or joint infection in index knee over the last 12 months.
16. Patient has an allergy to titanium alloy (Ti-6Al-4V), ultrahigh molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA).
17. Patient is pregnant or is planning to become pregnant (for female patients only) at any point during the duration of the study.
18. Patient has legal involvement or any other issue that would hinder completion of the two-year follow-up period.
19. Patient is participating in other studies and/or receiving any other simultaneous therapy in index knee.
20. Patient has an uncorrected tear of the meniscus of the index knee. (Partial meniscectomy that retains \>50% of the meniscus is allowed prior to or concurrently with the cartilage treatment procedure. Meniscus suture repair is allowed prior to or concurrently with the cartilage treatment procedure if \>50% of the functional meniscus remains.).
21. Patient has an additional cartilage lesion(s) (ICRS Grade 3 or 4) in the index knee, located on the patella, trochlea, tibia, or non-weight bearing area of index condyle that requires treatment.
22. More than one implant is required to accommodate defect in the index knee.
23. Patient has inadequate bone stock (e.g., cysts, osteoporosis) underlying the lesion site as determined intra-operatively by the investigator

    1. As determined by the investigator through use of an awl or a similar instrument to determine if the bone quality is insufficient to support the BioPoly device.
    2. If the cause of inadequate bone stock is due to cysts or to the boney portion of an osteochondral lesion being excessive, then the investigator may opt to fix the implant with cement rather than exclude the patient for inadequate bone stock.
24. Patients with osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease; a. Osteoporosis is defined as Simple Calculated Osteoporosis Risk Estimation (SCORE) above 6 and DXA T-score \< -2.5 or QCT T-score \< 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed

Where this trial is running

Fort Wayne, Indiana

• Dupont Hospital — Fort Wayne, Indiana, United States (Recruiting)

Study contacts

• Study coordinator: Sheila Schwartz, R.Ph.

Conditions Knee Pain Chronic; Knee Osteoarthritis; Cartilage Damage; Cartilage Defects of the Knee; Cartilage or Osteochondral Defects in the Knee; Cartilage Lesion; articular cartilage; cartilage lesion