Traumatic; LesionPhase 4RECORDNCT02981355
Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
A Phase 4 study testing Microfracture treatment and BST-CarGel in people with Traumatic; Lesion and Degenerative Lesion of Articular Cartilage of Knee, run by Piramal Healthcare Canada Ltd at 15 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic; Lesion, Degenerative Lesion of Articular Cartilage of Knee
- What is being tested?
- Microfracture treatment and BST-CarGel
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 26 Jul 2017to 6 Mar 2018
- Phase
- Phase 4
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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 previous 24 months
- has had surgical cartilage treatments in the index knee within previous 12 months
Show all 26Show fewer
- has had intra-articular injections in the index knee within the previous 2 months
- has diagnosis of an immunosuppressive disorder
- has a BMI > 30 kg/m2
- has concomitant healing bone fractures
- has a single lesion classified as focal, full-thickness grade 4B as defined by ICRS
- has noteworthy pain in the ipsilateral hip or ankle or contralateral hip, knee, or ankle
- has inflammatory arthropathy
- has blood clotting disorders, was receiving anticoagulant therapy, or has recurring deep vein thrombosis
- has a serious heart condition or liver and/or renal abnormalities diagnosed within the previous 24 months
- has chronic infection of the lower joint extremities
- has a history of alcohol or drug abuse within the previous 12 months
- is facing current or impending incarceration
- has a known allergy to shellfish
- is pregnant or plans to become pregnant during the course of the study
- in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, drug or alcohol abuse
- chronic knee pain
- has a documented medical history of vitamin-D deficiency that is not being managed with supplementation
- is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days
- requires an open procedure
- is known to be at risk for lost to follow-up, or failure to return for scheduled visits
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
Spain4 sites
Hospital Universitari del Mar
Barcelona, 08003
Hospital Quironsalud Barcelona
Barcelona, 08023
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Miguel Servet
Zaragoza, 50009
Canada3 sites
Banff Sport Medicine
Banff, T1L1B3
Fowler Kennedy Sport Medicine Clinic
London, N6A3K7
Hôpital Maisonneuve-Rosemont
Montreal, H1T4B3
Australia2 sites
Calvary Wakefield Hospital
Adelaide, 5000
Murdoch Orthopaedic Clinic
Murdoch, 6150
France2 sites
Hopital de La Croix-Rousse
Lyon, 69004
CHRU Nancy - Hospital Central
Nancy, 54000
United Kingdom2 sites
The Royal Orthopaedic Hospital
Birmingham, B312AP
University Hospital Southampton
Southampton, S0166YD
About this study
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.
Read the detailed description
The current standard of treatment for cartilage lesions on the femoral condyle is microfracture, which is conducted by penetrating the subchondral bone below the lesion. This procedure creates a natural healing response as a result of the bleeding and clotting caused by the microfracture, restoring the lesion. BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division), a liquid chitosan-containing polymer scaffolding, has been developed as an intra-articular injectable scaffold to aid in the stabilization of the blood clot created by microfracture. BST-CarGel does not interfere with the normal clotting process; however, it enables a prolonged healing time due to the increased stabilization of the clot within the lesion and the inhibition of clot retraction.
The RECORD trial is a multi-centre, randomized, controlled trial to assess the impact of the BST-CarGel scaffold and microfracture versus microfracture alone on short term clinical benefit as measured by loaded knee pain (single leg squat) on a visual analogue scale (3-6 months), mid-long term clinical benefit as measured by the same loaded knee pain (single leg squat) (9, 12, and 24 months) and Tegner Activity Score (TAS), International Knee Documentation Committee (IKDC), and Knee Injury and Osteoarthritis (KOOS) at 3, 6, 9, 12 and 24 months post-operatively. Approximately 158 participants with full-thickness grade III and IV cartilage lesions will be randomised in a 1:1 ratio to receive one of the two treatments during an arthroscopic procedure and will be followed for up to 24 months to collect outcomes.
- Being tested
- Microfracture treatment, BST-CarGel
- Keywords
- BST-CarGel, Microfracture, Cartilage Lesion, Chondral Lesion, Femoral condyle, Bone Marrow Stimulation, Cartilage Repair, Tear of Articular Cartilage of Knee, Current
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfracture treatmentProcedure or surgery
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
BST-CarGelDevice
BST-CarGel is combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following microfracture arthroscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Microfracture treatment | Active comparator | Microfracture surgery of the femoral condyle Receives: Procedure: Microfracture treatment |
| BST-CarGel plus microfracture treatment | Experimental | BST-CarGel combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following an arthroscopic microfracture surgery. Receives: Procedure: Microfracture treatment; Device: BST-CarGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in loaded knee pain (single leg squat) visual analogue scale (VAS)
Used to demonstrate patient clinical improvement. The VAS is one of the most commonly used measures of pain intensity, where the patient rates their pain on a scale from 0 to 10 (0=no pain; 10=maximum pain possible).
Measured: Baseline to 24 months post-surgery
Change in knee function measured by the TAS questionnaire
The TAS is a validated patient-administered questionnaire for use in multiple knee injuries and consists of a numerical scale ranging from 0 to 10 to indicate the ability to perform specific activities.
Measured: Baseline to 24 months post-surgery
Change in knee function measured by the IKDC questionnaire
The IKDC measures the progress in symptoms, function, and sports activities caused by knee impairment after a treatment has been performed. It can be used with reliability and validity in patients with a range of knee conditions.
Measured: Baseline to 24 months post-surgery
Change in knee function measured by the KOOS questionnaire
The KOOS is a measure of a patient's perceived knee pain and function, as well as associated problems with their knee status. It contains 42 items that are all recorded on a five-point Likert Scale by the patient.
Measured: Baseline to 24 months post-surgery
Secondary outcomes (3)
Repair tissue quantity and quality
Measured by MOCART Score and percentage lesion fill. The MOCART Score will be completed by two independent, blinded, well-trained radiologist readers.
Measured: Up to 24 months post-surgery
Adverse events related to treatment
Measured: Up to 24 months post-surgery
Economic evaluation
Measured by study-specific Resource Utilization Questionnaires which will be used to determine the costs associated with the use of the BST-CarGel scaffold treatment.
Measured: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start26 Jul 2017
- Primary completion6 Mar 2018
- Study completion6 Mar 2018
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic; LesionStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Healthcare Canada Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Smith & Nephew, Inc., Global Research Solutions
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Desmarais, Study chair, Piramal Healthcare Canada Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981355
- Sponsor's protocol ID
- BST-CarGel Pr001
- Acronym
- RECORD
- Status last verified
- Aug 2017
- First submitted
- 21 Nov 2016
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.
PubMed 26069709Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.
PubMed 24048551
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
- ClinicalTrials.gov ID
- NCT02981355
- Acronym / sponsor ID
- RECORD / BST-CarGel Pr001
- Keywords
- BST-CarGel, Microfracture, Cartilage Lesion, Chondral Lesion, Femoral condyle, Bone Marrow Stimulation, Cartilage Repair, Tear of Articular Cartilage of Knee, Current
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Piramal Healthcare Canada LtdIndustry (pharma, biotech, devices)
- Collaborators
- Smith & Nephew, Inc., Global Research Solutions
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 5 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.
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.
Detailed description
The current standard of treatment for cartilage lesions on the femoral condyle is microfracture, which is conducted by penetrating the subchondral bone below the lesion. This procedure creates a natural healing response as a result of the bleeding and clotting caused by the microfracture, restoring the lesion. BST-CarGel (Piramal Life Sciences, Bio-Orthopaedic Division), a liquid chitosan-containing polymer scaffolding, has been developed as an intra-articular injectable scaffold to aid in the stabilization of the blood clot created by microfracture. BST-CarGel does not interfere with the normal clotting process; however, it enables a prolonged healing time due to the increased stabilization of the clot within the lesion and the inhibition of clot retraction.
The RECORD trial is a multi-centre, randomized, controlled trial to assess the impact of the BST-CarGel scaffold and microfracture versus microfracture alone on short term clinical benefit as measured by loaded knee pain (single leg squat) on a visual analogue scale (3-6 months), mid-long term clinical benefit as measured by the same loaded knee pain (single leg squat) (9, 12, and 24 months) and Tegner Activity Score (TAS), International Knee Documentation Committee (IKDC), and Knee Injury and Osteoarthritis (KOOS) at 3, 6, 9, 12 and 24 months post-operatively. Approximately 158 participants with full-thickness grade III and IV cartilage lesions will be randomised in a 1:1 ratio to receive one of the two treatments during an arthroscopic procedure and will be followed for up to 24 months to collect outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfracture treatment | Active comparator | Procedure: Microfracture treatmentMicrofracture surgery of the femoral condyle |
| BST-CarGel plus microfracture treatment | Experimental | Procedure: Microfracture treatment, Device: BST-CarGelBST-CarGel combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following an arthroscopic microfracture surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (26 listed)
- 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 previous 24 months
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 |
|---|---|---|
| Microfracture treatmentMicrofracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response. | Procedure or surgery | BST-CarGel plus microfracture treatment, Microfracture treatment |
| BST-CarGelBST-CarGel is combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following microfracture arthroscopic surgery. | Device | BST-CarGel plus microfracture treatment |
Primary outcome
Change in loaded knee pain (single leg squat) visual analogue scale (VAS)
Time frame: Baseline to 24 months post-surgery
Used to demonstrate patient clinical improvement. The VAS is one of the most commonly used measures of pain intensity, where the patient rates their pain on a scale from 0 to 10 (0=no pain; 10=maximum pain possible).
Change in knee function measured by the TAS questionnaire
Time frame: Baseline to 24 months post-surgery
The TAS is a validated patient-administered questionnaire for use in multiple knee injuries and consists of a numerical scale ranging from 0 to 10 to indicate the ability to perform specific activities.
Change in knee function measured by the IKDC questionnaire
Time frame: Baseline to 24 months post-surgery
The IKDC measures the progress in symptoms, function, and sports activities caused by knee impairment after a treatment has been performed. It can be used with reliability and validity in patients with a range of knee conditions.
Change in knee function measured by the KOOS questionnaire
Time frame: Baseline to 24 months post-surgery
The KOOS is a measure of a patient's perceived knee pain and function, as well as associated problems with their knee status. It contains 42 items that are all recorded on a five-point Likert Scale by the patient.
3 secondary outcomes
Repair tissue quantity and quality
Time frame: Up to 24 months post-surgery
Adverse events related to treatment
Time frame: Up to 24 months post-surgery
Economic evaluation
Time frame: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Results publication: PubMed 26069709Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.
- Results publication: PubMed 24048551Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.
- 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.
Jean-Pierre Desmarais study chair
Piramal Healthcare Canada Ltd
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microfracture treatment and BST-CarGel in people with Traumatic; Lesion and Degenerative Lesion of Articular Cartilage of Knee, run by Piramal Healthcare Canada Ltd at 15 sites in 7 countries.
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 11 inclusion and 26 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: stopped early, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, Canada, Australia, France, United Kingdom and 2 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Change in loaded knee pain (single leg squat) visual analogue scale (VAS) (time frame: Baseline to 24 months post-surgery). The study lists 4 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 NCT02981355, which also lists 2 linked publications.
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 Nov 2018.