BioPoly® RS Partial Resurfacing Patella Registry Study

Cartilage Disease Clinical Trial

Official title:

Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02991300
• Other study ID #: 1251001 V2.0
• Status: Recruiting
• Start date: September 2016
• Est. completion date: September 2026

Study information

• Verified date: July 2022
• Source: BioPoly LLC
• Contact: Dinesh Nathwani, MD
• Phone: 02070346125
• Email: Info[@]precisionsurgery.co.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring of the clinical safety and performance of the device and surgical implantation kit

Description:

The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant This study will also allow monitoring of the clinical safety and performance of the device and surgical implantation kit

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 2026
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age 21 years and older

• Cartilage lesion(s) located in the facets of the patella that have failed prior therapy (conservative or surgical)

• Symptomatic lesions classified as ICRS grade 2, 3, or 4

• Lesion size may not exceed 3.1 cm2 and must be circumscribed by a 15 mm or 20 mm circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall depth less than 4 mm from the articulating surface

• Subchondral bone quality sufficient to support the implant

• Understanding and willingness to comply with the post-operative rehabilitation instructions and follow-up visits.

Exclusion Criteria:

• Body mass index (BMI) = 35

• Generalized degenerative or autoimmune arthritis

• Gout

• Uncorrected chronic malalignment of the patella (may be corrected at the same time as the implantation of the BioPoly device).

• Uncorrected ligamentous instability (may be corrected at the same time as the implantation of the BioPoly device).

• Kissing lesion on femur

• More than one implant required to accommodate lesion

• Allergy to ultra-high molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA)

• Use with opposing articulating femoral components

• Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee

• Pregnant, prisoner, vulnerable population, or unable to provide informed consent.

Related Conditions & MeSH terms

• Cartilage Disease
• Cartilage Diseases

Intervention

Device:
• BioPoly RS Partial Resurfacing Patella Implant

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Mid Yorkshire Hosp NHS	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
BioPoly LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS Subscores	KOOS	2 year post-op
Primary	Kujala Anterior Knee Pain Scale	Kujala	2 year post-op
Primary	Medical Outcomes Study (SF-36) for generic "quality of life"	SF-36	2 years post-op
Primary	Activity using Tegner Score	Tegner	2 years post-op
Primary	Pain using VAS Pain	VAS Pain	2 years post-op
Secondary	Radiographic Assessment	Radiographic Assessment	Annually through 5 years post-op