Cartilage DiseaseNCT02991300
BioPoly® RS Partial Resurfacing Patella Registry Study
An observational study of Cartilage Disease, run by BioPoly LLC at 2 sites in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cartilage Disease
- What is being tested?
- BioPoly RS Partial Resurfacing Patella Implant
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2016to Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Charing Cross Hospital
London, England, W1G 6HL
Mid Yorkshire Hosp NHS
Wakefield, WF1 4DG
About this study
Official title: Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant
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
Read the 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
- Conditions
- Cartilage Disease
- Being tested
- BioPoly RS Partial Resurfacing Patella Implant
- Keywords
- focal defect, focal lesion, chondral lesion, osteochondral lesion
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioPoly RS Partial Resurfacing Patella ImplantDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS Subscores
KOOS
Measured: 2 year post-op
Kujala Anterior Knee Pain Scale
Kujala
Measured: 2 year post-op
Medical Outcomes Study (SF-36) for generic "quality of life"
SF-36
Measured: 2 years post-op
Activity using Tegner Score
Tegner
Measured: 2 years post-op
Pain using VAS Pain
VAS Pain
Measured: 2 years post-op
Secondary outcomes (1)
Radiographic Assessment
Radiographic Assessment
Measured: Annually through 5 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 12 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- BioPoly LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dinesh Nathwani, MD, Principal investigator, Charing Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991300
- Sponsor's protocol ID
- 1251001 V2.0
- Status last verified
- Apr 2025
- First submitted
- 8 Dec 2016
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant
- ClinicalTrials.gov ID
- NCT02991300
- Acronym / sponsor ID
- 1251001 V2.0
- Conditions
- Cartilage Disease
- Keywords
- focal defect, focal lesion, chondral lesion, osteochondral lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BioPoly LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioPoly RS Partial Resurfacing Patella Implant | Device | – |
Primary outcome
KOOS Subscores
Time frame: 2 year post-op
KOOS
Kujala Anterior Knee Pain Scale
Time frame: 2 year post-op
Kujala
Medical Outcomes Study (SF-36) for generic "quality of life"
Time frame: 2 years post-op
SF-36
Activity using Tegner Score
Time frame: 2 years post-op
Tegner
Pain using VAS Pain
Time frame: 2 years post-op
VAS Pain
1 secondary outcome
Radiographic Assessment
Time frame: Annually through 5 years post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinesh Nathwani, MD principal investigator
Charing Cross Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Disease, run by BioPoly LLC at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS Subscores (time frame: 2 year post-op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.