Actively Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Led by BioPoly LLC · Updated on 2025-04-17
152
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
BioPoly® Partial Resurfacing Knee Implant IDE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is between 30 and 65 years of age
- KOOS quality of life score 60
- Willing and able to comply with study requirements including post-operative rehabilitation and follow-up
- Has a cartilage lesion in the femoral condyle or trochlear facet that has failed at least 2 months of non-surgical treatment or failed surgical treatment performed at least 12 months ago
- Lesion classified as ICRS grade 2, 3, or 4
- Lesion size not exceeding 3.1 cm2 and surrounded by mostly healthy cartilage
- Subchondral bone quality sufficient to support the implant as assessed during surgery
You will not qualify if you...
- Body mass index (BMI) 35 or higher
- Autoimmune arthritis diagnosis
- Advanced degenerative osteoarthritis in the affected knee (Kellgren-Lawrence Grade 4)
- Symptomatic cartilage, meniscal, or ligamentous lesions or osteoarthritis in the opposite knee
- Gout within the last 12 months
- Currently receiving non-surgical cartilage treatment for less than 2 months or surgical treatment less than 12 months ago
- Cartilage lesion that failed ACI, OATS, or Allograft treatment
- Malalignment of the affected knee greater than 5 degrees varus or valgus
- Bipolar cartilage involvement with severe opposing surface lesions
- Uncorrected ligament instability or significant joint movement deficits
- Total meniscectomy or patellofemoral arthroplasty in the affected knee
- Uncontrolled diabetes
- Conditions or medications impairing bone healing
- Recent active infection in the affected knee
- Allergy to device materials
- Pregnancy or planning pregnancy during study
- Legal or personal issues preventing completion of 2-year follow-up
- Participation in other studies or simultaneous knee therapies
- Uncorrected meniscus tear in the affected knee
- Additional severe cartilage lesions requiring treatment
- Need for more than one implant for the defect
- Inadequate bone stock for implant support
- Metabolic bone diseases like osteoporosis or Paget's disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dupont Hospital
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
Research Team
S
Sheila Schwartz, R.Ph.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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