BioPoly® RS Partial Resurfacing Patella Registry Study

• Sponsor: BioPoly LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT02991300
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Anticipated Duration (Months): 120
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cartilage Disease	Device: BioPoly RS Partial Resurfacing Patella Implant

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

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 35 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant
• Actual Study Start Date: Sep 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Sep 1, 2026

Outcome Measures

Primary Outcome Measures

1. KOOS Subscores [2 year post-op]

   KOOS

2. Kujala Anterior Knee Pain Scale [2 year post-op]

   Kujala

3. Medical Outcomes Study (SF-36) for generic "quality of life" [2 years post-op]

   SF-36

4. Activity using Tegner Score [2 years post-op]

   Tegner

5. Pain using VAS Pain [2 years post-op]

   VAS Pain

Secondary Outcome Measures

1. Radiographic Assessment [Annually through 5 years post-op]

   Radiographic Assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charing Cross Hospital	London	England	United Kingdom	W1G 6HL
2	Mid Yorkshire Hosp NHS	Wakefield		United Kingdom	WF1 4DG

Sponsors and Collaborators

• BioPoly LLC

Investigators

• Principal Investigator: Dinesh Nathwani, MD, Charing Cross Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BioPoly LLC
• ClinicalTrials.gov Identifier: NCT02991300
• Other Study ID Numbers: 1251001 V2.0
• First Posted: Dec 13, 2016
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by BioPoly LLC: focal defect; focal lesion; chondral lesion; osteochondral lesion
• Additional relevant MeSH terms: Cartilage Diseases

Study Results

No Results Posted as of Jul 20, 2022