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

This study is currently recruiting participants.
Verified August 2017 by Piramal Healthcare Canada Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981355
First Posted: December 5, 2016
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Smith & Nephew, Inc.
Global Research Solutions
Information provided by (Responsible Party):
Piramal Healthcare Canada Ltd
  Purpose
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.

Condition Intervention Phase
Traumatic; Lesion Degenerative Lesion of Articular Cartilage of Knee Procedure: Microfracture treatment Device: BST-CarGel Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions

Further study details as provided by Piramal Healthcare Canada Ltd:

Primary Outcome Measures:
  • Change in loaded knee pain 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.


Secondary Outcome Measures:
  • Repair tissue quantity and quality [ Time Frame: 12 and 24 months post-surgery ]
    Measured by MOCART II Score complemented by T2 MRI mapping. The MOCART II Score will be completed by two independent, blinded, well-trained radiologist readers.

  • Adverse events related to treatment [ Time Frame: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery ]
  • Quality of life [ Time Frame: 3,6,9,12 and 24 months post-surgery ]
    Measured by the EQ-5D-3L health questionnaire. The EQ-5D-3L health questionnaire is a standardized instrument utilized as a measure of health outcomes and can be applied to an extensive range of health conditions.

  • Economic evaluation [ Time Frame: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery ]
    Measured by a study-specific Resource Utilization Questionnaire which will be used to determine the costs associated with the use of the BST-CarGel scaffold treatment.


Estimated Enrollment: 158
Actual Study Start Date: July 26, 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Microfracture treatment
Microfracture surgery of the femoral condyle
Procedure: Microfracture treatment
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
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.
Procedure: Microfracture treatment
Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
Device: 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.

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 on a visual analogue scale (3-6 months), mid-long term clinical benefit as measured by the same loaded knee pain (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 moderate knee pain (loaded knee pain of a minimum 4 on a 10-cm VAS)
  • has a single lesion classified as focal, full-thickness grade 3 or 4 according to the ICRS (3A, B, 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 vitamin-D deficiency
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981355


Contacts
Contact: David A Pogorzelski, MSc 289-337-0857 david.pogorzelski@grsolutions.ca
Contact: Sheila Sprague, PhD 905-929-7846 sheila.sprague@grsolutions.ca

Locations
Australia
Calvary Wakefield Hospital Not yet recruiting
Adelaide, Australia, 5000
Principal Investigator: Andrew Comley, MD         
Murdoch Orthopaedic Clinic Not yet recruiting
Murdoch, Australia, 6150
Principal Investigator: Benjamin Jeffcote, MD         
Canada
Banff Sport Medicine Not yet recruiting
Banff, Canada, T1L1B3
Principal Investigator: Laurie Hiemstra, MD         
Fowler Kennedy Sport Medicine Clinic Not yet recruiting
London, Canada, N6A3K7
Principal Investigator: Alan Getgood, MD         
Hôpital Maisonneuve-Rosemont Not yet recruiting
Montreal, Canada, H1T4B3
Principal Investigator: Patrick Lavigne, MD         
France
Hopital de La Croix-Rousse Not yet recruiting
Lyon, France, 69004
Principal Investigator: Elvire Servien, MD         
CHRU Nancy - Hospital Central Not yet recruiting
Nancy, France, 54000
Principal Investigator: Didier Mainard, MD         
Germany
University Medical Centre Regensburg Recruiting
Regensburg, Germany, 93042
Principal Investigator: Peter Angele, MD         
Netherlands
Academic Medical Centre Not yet recruiting
Amsterdam, Netherlands, NL-1105 AZ
Principal Investigator: Gino Kerkhoffs, MD         
University Medical Centre Rotterdam Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Principal Investigator: Duncan Meuffels, MD         
Spain
Hospital Universitari del Mar Not yet recruiting
Barcelona, Spain, 08003
Principal Investigator: Juan Carlos Monllau Garcia, MD         
Hospital Quironsalud Barcelona Not yet recruiting
Barcelona, Spain, 08023
Principal Investigator: Ramon Cugat Bertomeu, MD         
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Principal Investigator: Nayana Joshi Jubert, MD         
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Principal Investigator: Carlos Martin Hernandez, MD         
Switzerland
SportClinic Zurich / Hirslanden Clinic Recruiting
Zurich, Switzerland, 8032
Principal Investigator: Matthias Steinwachs, MD         
United Kingdom
The Royal Orthopaedic Hospital Not yet recruiting
Birmingham, United Kingdom, B312AP
Principal Investigator: Martyn Snow, MD         
Royal Alexandra Hospital Not yet recruiting
Glasgow, United Kingdom, PA29PN
Principal Investigator: Tom Nunn, MD         
University Hospital Southampton Not yet recruiting
Southampton, United Kingdom, S016 6YD
Principal Investigator: Gorav Datta, MD         
Sponsors and Collaborators
Piramal Healthcare Canada Ltd
Smith & Nephew, Inc.
Global Research Solutions
Investigators
Study Chair: Jean-Pierre Desmarais Piramal Healthcare Canada Ltd
  More Information

Publications:
Responsible Party: Piramal Healthcare Canada Ltd
ClinicalTrials.gov Identifier: NCT02981355     History of Changes
Other Study ID Numbers: BST-CarGel Pr001
First Submitted: November 21, 2016
First Posted: December 5, 2016
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Piramal Healthcare Canada Ltd:
BST-CarGel
Microfracture
Cartilage Lesion, Chondral Lesion
Femoral condyle
Bone Marrow Stimulation
Cartilage Repair
Tear of Articular Cartilage of Knee, Current

Additional relevant MeSH terms:
Fractures, Stress
Fractures, Bone
Wounds and Injuries