TerminatedPhase 4

Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions

Stopped: Lack of funding

Australia, Canada, France5 participantsStarted 2017-07-26

Plain-language summary

This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold with microfracture versus microfracture alone on short and long term clinical benefit in patients with cartilage lesions of the femoral condyle requiring operative management.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * requires cartilage repair treatment due to distal femoral cartilage lesion * is 18-55 years of age at the time of surgery * has single, focal cartilage lesion on one of the femoral condyles * has symptomatic cartilage lesion that has failed conservative management * has a single lesion classified as focal, full-thickness grade 3 or 4 according to the ICRS (3A, 3B, 3C, 3D and 4A) * an area of lesion between 1.5-3 cm2 after debridement * has a stable knee (\<5-mm side-to-side difference on Lachman and varus and valgus stress testing and grade 0 or 1 on the pivot-shift test) and an intact meniscal rim * is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires and recommended physiotherapy regimen * has agreed to discontinue the use of all knee pain medication 3 days before the pre-treatment visit and the post-treatment follow-up visits at 3, 6, 9, 12, and 24 months * has consented to participating in the study by signing the IRB/EC approved informed consent form * no deep osteochondral defect ( \< 5 mm bone loss) Exclusion Criteria: * has multiple lesions or kissing (opposing) lesion(s) greater than GII * has clinically relevant compartment malalignment (\>5°) * has bone cyst(s) associated with, or adjacent to, the index lesion * has Osteochondritis Dissecans with bone or bone-cartilage fragment in place * has had ligament treatments in the index knee within the previo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in loaded knee pain (single leg squat) visual analogue scale (VAS)

Timeframe: Baseline to 24 months post-surgery

Change in knee function measured by the TAS questionnaire

Timeframe: Baseline to 24 months post-surgery

Change in knee function measured by the IKDC questionnaire

Timeframe: Baseline to 24 months post-surgery

Change in knee function measured by the KOOS questionnaire

Timeframe: Baseline to 24 months post-surgery

Trial details

NCT IDNCT02981355

SponsorPiramal Healthcare Canada Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-06

View on ClinicalTrials.gov More Traumatic; Lesion trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in loaded knee pain (single leg squat) visual analogue scale (VAS)

Timeframe: Baseline to 24 months post-surgery

Change in knee function measured by the TAS questionnaire

Timeframe: Baseline to 24 months post-surgery

Change in knee function measured by the IKDC questionnaire

Timeframe: Baseline to 24 months post-surgery

Change in knee function measured by the KOOS questionnaire

Timeframe: Baseline to 24 months post-surgery