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.
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 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.
Parallel
BioPoly
Devicepartial resurfacing knee replacement
surgical standard of care (SSOC)
Procedure/Surgeryeither microfracture or debridement
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.
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.
Effectiveness over 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS)
KOOS individual component sub-scales (Pain, Symptoms, Activities of Daily Living, Sports/Recreation, Quality of Life) as measured by change from baseline at 6 weeks, 3, 6, 12, and 24 months. The minimum and maximum raw scores for each sub-scale is as follows: Pain = 0-36, Symptoms = 0-28, Activities of Daily Living = 0-38, Sports/Recreation = 20, Quality of Life = 0-16. The sub-scales will be reported on a normalized scale relative the maximum raw score for the particular sub-scale, thus, each sub-scale score will have a range of 0-100 with 100 being better. For instance, a subject's Quality of Life raw score of 12 would be normalized as 12/16 x 100 = 75 points. The reported number will be the difference between the normalized score at a particular timepoint minus the baseline normalized score.
Effectiveness pain reduction over 24 months
Variable Analog Scale (VAS) Pain score as measured by change from baseline at 6 weeks, 3, 6, 12, and 24 months. The VAS Pain score ranges from 0-100 where a lower number is a measure of less pain; so, lower VAS Pain scores are better.
Adverse Events Over 24 Months
* Serious device-related adverse events through 24 months * Device-related adverse events through 24 months * Serious adverse events through 24 months * Unanticipated adverse device effects (UADE) through 24 months
Radiograph review to Assess Implant Stability Over 24 Months
Implant stability over time is assessed by monitoring implant migration/subsidence, implant loosening, and radiolucencies around the implant at 24 months.
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