An interventional study of BioPoly RS Partial Resurfacing Knee Implant in Cartilage Injury, Defect of Articular Cartilage and Cartilage Damage, sponsored by BioPoly LLC. Completed at 5 sites in United Kingdom. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by BioPoly LLC · Not applicable, Interventional, and Treatment
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device. Patients will be followed for 5 years after surgery.
73 studies on the registry are indexed under Cartilage Diseases; 5 are open to participants now.
This study's enrollment of 38 is below the median of 47 across 49 interventional studies indexed under Cartilage Diseases.
Browse Cartilage Diseases studies →BioPoly LLC is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BioPoly RS Implant
Device: BioPoly RS Partial Resurfacing Knee Implant
A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
Time frame: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
Time frame: 2 years
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
Time frame: Through 5 years
VAS Pain
Visual analogue scale for assessment of pain
Time frame: Through 5 years
Tegner Activity
Measurement of patient's activity level
Time frame: Through 5 years
SF-36
Assessment of patient's overall quality of life
Time frame: Through 5 years
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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BioPoly LLC