Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions (RECORD)
Primary Purpose
Traumatic; Lesion, Degenerative Lesion of Articular Cartilage of Knee
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Microfracture treatment
BST-CarGel
Sponsored by
About this trial
This is an interventional basic science trial for Traumatic; Lesion focused on measuring BST-CarGel, Microfracture, Cartilage Lesion, Chondral Lesion, Femoral condyle, Bone Marrow Stimulation, Cartilage Repair, Tear of Articular Cartilage of Knee, Current
Eligibility Criteria
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 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
Sites / Locations
- Calvary Wakefield Hospital
- Murdoch Orthopaedic Clinic
- Banff Sport Medicine
- Fowler Kennedy Sport Medicine Clinic
- Hôpital Maisonneuve-Rosemont
- Hopital de La Croix-Rousse
- CHRU Nancy - Hospital Central
- University Medical Centre Regensburg
- Hospital Universitari del Mar
- Hospital Quironsalud Barcelona
- Hospital Universitari Vall d'Hebron
- Hospital Universitario Miguel Servet
- SportClinic Zurich / Hirslanden Clinic
- The Royal Orthopaedic Hospital
- University Hospital Southampton
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Microfracture treatment
BST-CarGel plus microfracture treatment
Arm Description
Microfracture surgery of the femoral condyle
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
Secondary Outcome Measures
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.
Adverse events related to treatment
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.
Full Information
NCT ID
NCT02981355
First Posted
November 21, 2016
Last Updated
October 30, 2018
Sponsor
Piramal Healthcare Canada Ltd
Collaborators
Smith & Nephew, Inc., Global Research Solutions
1. Study Identification
Unique Protocol Identification Number
NCT02981355
Brief Title
Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
Acronym
RECORD
Official Title
Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
March 6, 2018 (Actual)
Study Completion Date
March 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Piramal Healthcare Canada Ltd
Collaborators
Smith & Nephew, Inc., Global Research Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic; Lesion, Degenerative Lesion of Articular Cartilage of Knee
Keywords
BST-CarGel, Microfracture, Cartilage Lesion, Chondral Lesion, Femoral condyle, Bone Marrow Stimulation, Cartilage Repair, Tear of Articular Cartilage of Knee, Current
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microfracture treatment
Arm Type
Active Comparator
Arm Description
Microfracture surgery of the femoral condyle
Arm Title
BST-CarGel plus microfracture treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microfracture treatment
Intervention Description
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
Intervention Type
Device
Intervention Name(s)
BST-CarGel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in loaded knee pain (single leg squat) visual analogue scale (VAS)
Description
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).
Time Frame
Baseline to 24 months post-surgery
Title
Change in knee function measured by the TAS questionnaire
Description
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.
Time Frame
Baseline to 24 months post-surgery
Title
Change in knee function measured by the IKDC questionnaire
Description
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.
Time Frame
Baseline to 24 months post-surgery
Title
Change in knee function measured by the KOOS questionnaire
Description
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.
Time Frame
Baseline to 24 months post-surgery
Secondary Outcome Measure Information:
Title
Repair tissue quantity and quality
Description
Measured by MOCART Score and percentage lesion fill. The MOCART Score will be completed by two independent, blinded, well-trained radiologist readers.
Time Frame
Up to 24 months post-surgery
Title
Adverse events related to treatment
Time Frame
Up to 24 months post-surgery
Title
Economic evaluation
Description
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.
Time Frame
surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Desmarais
Organizational Affiliation
Piramal Healthcare Canada Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Calvary Wakefield Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Murdoch Orthopaedic Clinic
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Banff Sport Medicine
City
Banff
ZIP/Postal Code
T1L1B3
Country
Canada
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
ZIP/Postal Code
N6A3K7
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montreal
ZIP/Postal Code
H1T4B3
Country
Canada
Facility Name
Hopital de La Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
CHRU Nancy - Hospital Central
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
University Medical Centre Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Hospital Universitari del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
SportClinic Zurich / Hirslanden Clinic
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
The Royal Orthopaedic Hospital
City
Birmingham
ZIP/Postal Code
B312AP
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
ZIP/Postal Code
S0166YD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26069709
Citation
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.
Results Reference
result
PubMed Identifier
24048551
Citation
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.
Results Reference
result
Learn more about this trial
Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
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