Clinical trial NCT02991300: BioPoly® RS Partial Resurfacing Patella Registry Study
Official title: Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cartilage Disease
Keywords: focal defect
focal lesion
chondral lesion
osteochondral lesion
Lead sponsor: BioPoly LLC
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

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

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.

Primary outcomes:
measure: KOOS Subscores
timeFrame: 2 year post-op
measure: Kujala Anterior Knee Pain Scale
timeFrame: 2 year post-op
measure: Medical Outcomes Study (SF-36) for generic "quality of life"
timeFrame: 2 years post-op
measure: Activity using Tegner Score
timeFrame: 2 years post-op
measure: Pain using VAS Pain
timeFrame: 2 years post-op
Secondary outcomes:
measure: Radiographic Assessment
timeFrame: Annually through 5 years post-op
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Hosp NHS
Study officials:
affiliation: Charing Cross Hospital
name: Dinesh Nathwani, MD
role: PRINCIPAL_INVESTIGATOR
References: