BioPoly® Partial Resurfacing Knee Implant IDE

Part of paid clinical trials in Fort Wayne, Indiana.

Sponsor
BioPoly LLC
Study ID
NCT06915363
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • BioPoly — DEVICE
    partial resurfacing knee replacement
  • surgical standard of care (SSOC) — PROCEDURE
    either microfracture or debridement

Study Details

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.

Key Dates

Start date
Mar 17, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Investigational
    BioPoly Knee device
  • Active Comparator: Control
    Surgical Standard of Care Group: either Microfracture or debridement procedure

Primary Outcome Measure

Improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) to Assess Composite Clinical Success (CCS) effectiveness [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dupont HospitalFort WayneIndiana46845
Ian Nelson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Wayne, IN

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Dupont Hospital· Fort Wayne, IN

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