NCT01473199

BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: BioPoly LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cartilage Injury
• Defect of Articular Cartilage
• Cartilage Damage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-12-01
• Completion: 2021-12-01
• First posted: 2011-11-17
• Last updated: 2022-02-01

Locations

5 sites across 1 country: United Kingdom