Actively Recruiting
Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly4 Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur
Led by BioPoly LLC · Updated on 2025-04-17
152
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the BioPoly4 Partial Resurfacing Knee Implant for treating cartilage defects in the distal femur of adults with knee pain who need surgical intervention. This clinical trial compares outcomes of the BioPoly device to standard surgical care, which includes microfracture or debridement procedures, in patients with specific cartilage lesions. The study aims to demonstrate improved knee function and reduced need for additional surgeries over 24 months. Participants will be randomly assigned to receive either the BioPoly Knee device or the standard surgical care. The BioPoly device is designed to replace damaged cartilage in the femoral condyles or trochlear facets in patients aged 30 to 65 with certain lesion characteristics. The control group will undergo microfracture or debridement based on factors like age, lesion size, and osteoarthritis severity. Treatments are surgical and early interventions before joint replacement. During the 24-month study, participants will be monitored for knee function using the Knee injury and Osteoarthritis Outcome Score (KOOS) and checked for the need for secondary surgeries. Safety will be assessed by tracking adverse events and implant stability through radiographs. Researchers will measure pain reduction and overall treatment success, with follow-up visits including clinical assessments and imaging to evaluate outcomes and implant survival.
CONDITIONS
Brief 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 is 60 or less.
- Patient understands and agrees to follow all study requirements including post-operative rehab and follow-up.
- Patient has a cartilage lesion that has failed at least 2 months of non-surgical treatment or failed surgical treatment performed at least 12 months ago.
- Cartilage lesion is located in the femoral condyle or trochlear facet.
- Lesion is classified as ICRS grade 2, 3, or 4.
- Lesion size does not exceed 3.1 cm2 and is surrounded by normal or nearly normal cartilage.
- Subchondral bone quality is sufficient to support the implant, as assessed during surgery.
You will not qualify if you...
- Body mass index (BMI) is 35 or higher.
- Diagnosis of autoimmune arthritis.
- Advanced degenerative osteoarthritis in the affected knee (Kellgren-Lawrence Grade 4).
- Contralateral knee has symptomatic cartilage, meniscal, or ligament lesions or requires surgery.
- History of gout within the last 12 months.
- Cartilage lesion currently treated with non-surgical therapy started less than 2 months ago or failed surgical therapy within 12 months.
- Cartilage lesion failed ACI, OATS, or Allograft treatment.
- Malalignment of the knee greater than 5 degrees varus or valgus.
- Bipolar articular cartilage involvement greater than ICRS Grade 2.
- Uncorrected ligament instability in the affected knee.
- Total meniscectomy or patellofemoral arthroplasty of the affected knee.
- Uncontrolled diabetes.
- Conditions or treatments impairing bone healing.
- Active infection in the affected knee in the last 12 months.
- Allergy to titanium alloy, polyethylene, or hyaluronic acid.
- Pregnancy or plans to become pregnant during the study.
- Legal or personal issues preventing completion of follow-up.
- Participation in other studies or therapies for the affected knee.
- Uncorrected meniscus tear with less than 50% meniscus remaining.
- Additional high-grade cartilage lesions requiring treatment.
- Need for more than one implant in the affected knee.
- Inadequate bone stock under the lesion site as assessed during surgery.
- Metabolic bone diseases such as osteoporosis or Paget's disease with specific diagnostic criteria met.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day to 1 week
Participants undergo surgical intervention with either the BioPoly knee implant or the surgical standard of care (microfracture or debridement). Immediate post-operative care follows surgery.
1 surgical visit and initial post-operative care visits
Duration - Up to 24 months
Participants attend follow-up visits to monitor recovery, knee function, and implant stability. Assessments include clinical outcomes and safety monitoring.
Multiple follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Dupont Hospital
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
Research Team
S
Sheila Schwartz, R.Ph.
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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