BioPoly® RS Partial Resurfacing Patella Registry Study | NCT02991300

Studies
BioPoly® RS Partial Resurfacing Patella Registry Study

NCT02991300

Sponsor

BioPoly LLC

Status

Completed

Last Update Posted

Apr 16, 2025Actual

Enrollment

12Estimated

Phase

Not provided

Conditions

Cartilage Disease

Interventions

BioPoly RS Partial Resurfacing Patella Implant

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Dec 2024Actual

Completion Date

Dec 2024Actual

First Submitted Date

Dec 8, 2016

First Submission Date that Met QC Criteria

Dec 12, 2016

First Posted Date

Dec 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2025

Last Update Posted Date

Apr 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Name	Type	Description	Arm Group Labels	Other Names
BioPoly RS Partial Resurfacing Patella Implant	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
KOOS Subscores	KOOS	2 year post-op
Kujala Anterior Knee Pain Scale	Kujala	2 year post-op
Medical Outcomes Study (SF-36) for generic "quality of life"	SF-36	2 years post-op
Activity using Tegner Score	Tegner	2 years post-op
Pain using VAS Pain	VAS Pain	2 years post-op

Secondary Outcomes

Measure	Description	Time Frame
Radiographic Assessment	Radiographic Assessment	Annually through 5 years post-op

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The population who will participate in this clinical study includes those patients 21 years of age or older who otherwise meet the inclusion/exclusion criteria.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Charing Cross Hospital		London	England	W1G 6HL	United Kingdom
Mid Yorkshire Hosp NHS

ID	Term
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases