Cartilage InjuryNCT01473199

BioPoly RS Knee Registry Study for Cartilage Defect Replacement

A study testing BioPoly RS Partial Resurfacing Knee Implant in people with Cartilage Injury and Defect of Articular Cartilage, run by BioPoly LLC at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Cartilage Injury, Defect of Articular Cartilage, Cartilage Damage
What is being tested?: BioPoly RS Partial Resurfacing Knee Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 5 sitesUnited Kingdom
Study dates: Nov 2011to Dec 2021
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical)
Lesion classified as ICRS Grade 2, 3, or 4

Who cannot join

Body mass index (BMI) of 30 or more
Osteoarthritis or rheumatoid arthritis
Gout
Uncorrected mal-alignment, ligamentous instability, or meniscal tear
Total meniscectomy
Kissing lesion on tibia

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United Kingdom5 sites

Chester Knee Clinic, Nuffield Health The Grosvenor Hospital Chester
Chester, England, CH4 7QP
Aintree University Hospital
Liverpool, England, L9 7AL
The London Clinic
London, England, W1G 6HL
Charing Cross Hospital
London, England, W6 8RF
Royal National Orthopaedic Hospital
Stanmore, England, HA7 4LP

Other trials in United Kingdom

About this study

Official title: Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant

Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.

Read the detailed description

Conditions: Cartilage Injury, Defect of Articular Cartilage, Cartilage Damage
Being tested: BioPoly RS Partial Resurfacing Knee Implant
Keywords: focal defect, focal lesion, chondral lesion, osteochondral lesion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BioPoly RS Partial Resurfacing Knee ImplantDevice
A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.

Study groups in NCT01473199
Study group	Role	What they receive
BioPoly RS Implant	Experimental	BioPoly RS Implant Receives: Device: BioPoly RS Partial Resurfacing Knee Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
Measured: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
Measured: 2 years

Secondary outcomes (4)

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function assessment
Measured: Through 5 years
VAS Pain
Visual analogue scale for assessment of pain
Measured: Through 5 years
Tegner Activity
Measurement of patient's activity level
Measured: Through 5 years
SF-36
Assessment of patient's overall quality of life
Measured: Through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Dec 2021

First posted17 Nov 2011 (estimated)
Study startNov 2011
Primary completionDec 2016
Study completionDec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cartilage InjuryStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01473199
Sponsor's protocol ID: 1151001
Status last verified: Jan 2022
First submitted: 10 Nov 2011
Last updated: 1 Feb 2022
Results posted: No
Data monitoring committee: No

Publications

Nathwani D, McNicholas M, Hart A, Miles J, Bobic V. Partial Resurfacing of the Knee with the BioPoly Implant: Interim Report at 2 Years. JB JS Open Access. 2017 Apr 6;2(2):e0011. doi: 10.2106/JBJS.OA.16.00011. eCollection 2017 Jun 26.
PubMed 30229214

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
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All Cartilage Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant
ClinicalTrials.gov ID: NCT01473199
Acronym / sponsor ID: 1151001
Conditions: Cartilage Injury, Defect of Articular Cartilage, Cartilage Damage
Keywords: focal defect, focal lesion, chondral lesion, osteochondral lesion
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: BioPoly LLCIndustry (pharma, biotech, devices)
Study start: Nov 2011 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2021 (actual)
First posted: 17 Nov 2011 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BioPoly RS Implant	Experimental	Device: BioPoly RS Partial Resurfacing Knee ImplantBioPoly RS Implant

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical)
Lesion classified as ICRS Grade 2, 3, or 4

Key exclusion criteria (6 listed)

Body mass index (BMI) of 30 or more
Osteoarthritis or rheumatoid arthritis
Gout
Uncorrected mal-alignment, ligamentous instability, or meniscal tear
Total meniscectomy

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 Knee ImplantA long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.	Device	BioPoly RS Implant

Primary outcome

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 months
Knee function assessment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 2 years
Knee function assessment

4 secondary outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Through 5 years
VAS Pain
Time frame: Through 5 years
Tegner Activity
Time frame: Through 5 years
SF-36
Time frame: Through 5 years

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 1 Feb 2022.
Results publication: PubMed 30229214Nathwani D, McNicholas M, Hart A, Miles J, Bobic V. Partial Resurfacing of the Knee with the BioPoly Implant: Interim Report at 2 Years. JB JS Open Access. 2017 Apr 6;2(2):e0011. doi: 10.2106/JBJS.OA.16.00011. eCollection 2017 Jun 26.

Related trials for Cartilage Injury

Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
RecruitingObservational study
Knee Cartilage Repair Registry
Knee Injuries, Joint Surface Knee Lesions
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect

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.

Vladimir Bobic, MD study chair

Nuffield Health, The Grosvenor Hospital Chester

Dinesh Nathwani, MD principal investigator

The London Clinic

Michael McNicholas, MD principal investigator

Aintree University Hospital

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BioPoly RS Partial Resurfacing Knee Implant in people with Cartilage Injury and Defect of Articular Cartilage, run by BioPoly LLC at 5 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 2 inclusion and 6 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01473199, which also lists 1 linked publication.

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 1 Feb 2022.