BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Cartilage Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473199
• Other study ID #: 1151001
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2021

Study information

• Verified date: January 2022
• Source: BioPoly LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical)

• Lesion classified as ICRS Grade 2, 3, or 4

Exclusion Criteria:

• Body mass index (BMI) of 30 or more

• Osteoarthritis or rheumatoid arthritis

• Gout

• Uncorrected mal-alignment, ligamentous instability, or meniscal tear

• Total meniscectomy

• Kissing lesion on tibia

Related Conditions & MeSH terms

• Cartilage Damage
• Cartilage Diseases
• Cartilage Injury
• Defect of Articular Cartilage

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester	Chester	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	The London Clinic	London	England
United Kingdom	Royal National Orthopaedic Hospital	Stanmore	England

Sponsors (1)

Lead Sponsor	Collaborator
BioPoly LLC

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Nathwani D, McNicholas M, Hart A, Miles J, Bobic V. Partial Resurfacing of the Knee with the BioPoly Implant: Interim Report at 2 Years. JB JS Open Access. 2017 Apr 6;2(2):e0011. doi: 10.2106/JBJS.OA.16.00011. eCollection 2017 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee function assessment	6 months
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee function assessment	2 years
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee function assessment	Through 5 years
Secondary	VAS Pain	Visual analogue scale for assessment of pain	Through 5 years
Secondary	Tegner Activity	Measurement of patient's activity level	Through 5 years
Secondary	SF-36	Assessment of patient's overall quality of life	Through 5 years