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Trial record 2 of 2 for:    biopoly

BioPoly® RS Partial Resurfacing Patella Registry Study

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ClinicalTrials.gov Identifier: NCT02991300
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
BioPoly LLC

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
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 Type : Observational [Patient Registry]
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : September 2024



Primary Outcome Measures :
  1. KOOS Subscores [ Time Frame: 2 year post-op ]
  2. Kujala Anterior Knee Pain Scale [ Time Frame: 2 year post-op ]
  3. Medical Outcomes Study (SF-36) for generic "quality of life" [ Time Frame: 2 years post-op ]
  4. Activity using Tegner Score [ Time Frame: 2 years post-op ]
  5. Pain using VAS Pain [ Time Frame: 2 years post-op ]

Secondary Outcome Measures :
  1. Radiographic Assessment [ Time Frame: Annually through 5 years post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991300


Locations
United Kingdom
The London Clinic Recruiting
London, England, United Kingdom, W1G 6HL
Contact: Dinesh Nathwani       info@precisionsurgery.co.uk   
Principal Investigator: Dinesh Nathwani, MD         
Sponsors and Collaborators
BioPoly LLC

Responsible Party: BioPoly LLC
ClinicalTrials.gov Identifier: NCT02991300     History of Changes
Other Study ID Numbers: 1251001 V2.0
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by BioPoly LLC:
focal defect
focal lesion
chondral lesion
osteochondral lesion

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases