BioPoly® Partial Resurfacing Knee Implant IDE

NCT06915363 | Recruiting FDA Device

• 1 other identifier: 1150117
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by:

• no secondary surgical intervention (SSI) and
• an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement). Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.

Conditions

Knee Pain Chronic; Knee Osteoarthritis; Cartilage Damage; Cartilage Defects of the Knee; Cartilage or Osteochondral Defects in the Knee; Cartilage Lesion

Keywords

articular cartilage; cartilage lesion; focal cartilage defect; cartilage defect

Outcome Measures

Primary Outcomes (2)

• Improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) to Assess Composite Clinical Success (CCS) effectiveness

  An improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. If this criteria is met, the subject will be considered as a success relative to the measure of the Clinical Composite Success for effectiveness.

  24 months

• Composite Clinical Success (CCS) Safety as Measured by No Secondary Surgical Intenvention

  No secondary surgical intervention (SSI) by 24 months will be considered as a success for the subject relative to the Composite Clinical Success (CCS) for Safety.

  24 months

Secondary Outcomes (5)

• Effectiveness over 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS)

  24 months

• Effectiveness pain reduction over 24 months

  24 months

• Adverse Events Over 24 Months

  24 months

• Radiograph review to Assess Implant Stability Over 24 Months

  24 months

• Survival Over 24 Months

  24 months

Study Arms (2)

Investigational

ACTIVE COMPARATOR

BioPoly Knee device

Device: BioPoly

Control

ACTIVE COMPARATOR

Surgical Standard of Care Group: either Microfracture or debridement procedure

Procedure: surgical standard of care (SSOC)

Interventions

BioPoly DEVICE

partial resurfacing knee replacement

Investigational

surgical standard of care (SSOC) PROCEDURE

either microfracture or debridement

Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is between 30 and 65 years of age25.
• KOOS quality of life score ≤ 60.
• 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.
• 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.
• Patient has cartilage lesion located in the femoral condyle or trochlear facet.
• Patient has lesion(s) classified as ICRS grade 2, 3 or 4.
• 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.
• 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.

You may not qualify if:

• Patient has body mass index (BMI) ≥ 35.
• Patient has autoimmune arthritis, as diagnosed by Investigator.
• Patient has advanced degenerative osteoarthritis in index knee (Kellgren-Lawrence Grade 4 and/or diagnosed intraoperatively).
• Contralateral knee is known to have symptomatic cartilage, meniscal, or ligamentous lesions, generalized osteoarthritis, or requires surgery.
• Patient has gout, by Investigator diagnosis or patient-reported history within last 12 months.
• 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.
• Patient has a cartilage lesion that is being treated that has failed ACI, OATS or Allograft treatment.
• Patient has malalignment of the index knee (\>5 degrees weight bearing varus or valgus).
• 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.
• 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.
• Patient has undergone a total meniscectomy of index knee.
• Patient has undergone patellofemoral arthroplasty of the index knee
• Patient currently reports or has a documented history of uncontrolled diabetes.
• Patient currently has any condition, therapy, or medication known to impair bone healing.
• Patient has had an active systemic infection or joint infection in index knee over the last 12 months.

Sponsors & Collaborators

• BioPoly LLC: lead

Study Sites (1)

Dupont Hospital

Fort Wayne, Indiana, 46845, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Herb Schwartz, Ph.D.

  BioPoly LLC

  STUDY DIRECTOR

Central Study Contacts

Sheila Schwartz, R.Ph.

CONTACT

2609996135; sheila@biopolyortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized 1:1

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 8, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)