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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - 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).
Timepoint [1] 0 0
Baseline to 24 months post-surgery
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline to 24 months post-surgery
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline to 24 months post-surgery
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline to 24 months post-surgery
Secondary outcome [1] 0 0
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.
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 - 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.
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
Gender
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
Basic Science
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT02981355
Trial related presentations / publications
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/show/NCT02981355