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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02981355




Registration number
NCT02981355
Ethics application status
Date submitted
21/11/2016
Date registered
5/12/2016
Date last updated
1/11/2018

Titles & IDs
Public title
Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
Scientific title
Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
Secondary ID [1] 0 0
BST-CarGel Pr001
Universal Trial Number (UTN)
Trial acronym
RECORD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic; Lesion 0 0
Degenerative Lesion of Articular Cartilage of Knee 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Microfracture treatment
Treatment: Devices - BST-CarGel

Active comparator: Microfracture treatment - Microfracture surgery of the femoral condyle

Experimental: BST-CarGel plus microfracture treatment - 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.


Treatment: Surgery: Microfracture treatment
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.

Treatment: Devices: BST-CarGel
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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in loaded knee pain (single leg squat) visual analogue scale (VAS)
Timepoint [1] 0 0
Baseline to 24 months post-surgery
Primary outcome [2] 0 0
Change in knee function measured by the TAS questionnaire
Timepoint [2] 0 0
Baseline to 24 months post-surgery
Primary outcome [3] 0 0
Change in knee function measured by the IKDC questionnaire
Timepoint [3] 0 0
Baseline to 24 months post-surgery
Primary outcome [4] 0 0
Change in knee function measured by the KOOS questionnaire
Timepoint [4] 0 0
Baseline to 24 months post-surgery
Secondary outcome [1] 0 0
Repair tissue quantity and quality
Timepoint [1] 0 0
Up to 24 months post-surgery
Secondary outcome [2] 0 0
Adverse events related to treatment
Timepoint [2] 0 0
Up to 24 months post-surgery
Secondary outcome [3] 0 0
Economic evaluation
Timepoint [3] 0 0
surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 previous 24 months
* has had surgical cartilage treatments in the index knee within previous 12 months
* 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2018
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [2] 0 0
Murdoch Orthopaedic Clinic - Murdoch
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Banff
Country [2] 0 0
Canada
State/province [2] 0 0
London
Country [3] 0 0
Canada
State/province [3] 0 0
Montreal
Country [4] 0 0
France
State/province [4] 0 0
Lyon
Country [5] 0 0
France
State/province [5] 0 0
Nancy
Country [6] 0 0
Germany
State/province [6] 0 0
Regensburg
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Zaragoza
Country [9] 0 0
Switzerland
State/province [9] 0 0
Zurich
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Birmingham
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Piramal Healthcare Canada Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Smith & Nephew, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Global Research Solutions
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02981355
Trial related presentations / 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.
Stanish 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.
Public notes

Contacts
Principal investigator
Name 0 0
Jean-Pierre Desmarais
Address 0 0
Piramal Healthcare Canada Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02981355