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

NCT ID: NCT02981355

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2018-03-06

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.

Conditions

Traumatic; Lesion; Degenerative Lesion of Articular Cartilage of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Microfracture treatment

Microfracture surgery of the femoral condyle

Group Type: ACTIVE_COMPARATOR

Microfracture treatment

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Microfracture treatment

Intervention Type: PROCEDURE

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

BST-CarGel

Intervention Type: DEVICE

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.

Interventions

Microfracture treatment

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

Intervention Type: PROCEDURE

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 Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

Global Research Solutions

INDUSTRY

Sponsor Role: collaborator

Piramal Healthcare Canada Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre Desmarais

Role: STUDY_CHAIR

Piramal Healthcare Canada Ltd

Locations

Calvary Wakefield Hospital

Adelaide, , Australia

Murdoch Orthopaedic Clinic

Murdoch, , Australia

Banff Sport Medicine

Banff, , Canada

Fowler Kennedy Sport Medicine Clinic

London, , Canada

Hôpital Maisonneuve-Rosemont

Montreal, , Canada

Hopital de La Croix-Rousse

Lyon, , France

CHRU Nancy - Hospital Central

Nancy, , France

University Medical Centre Regensburg

Regensburg, , Germany

Hospital Universitari del Mar

Barcelona, , Spain

Hospital Quironsalud Barcelona

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

SportClinic Zurich / Hirslanden Clinic

Zurich, , Switzerland

The Royal Orthopaedic Hospital

Birmingham, , United Kingdom

University Hospital Southampton

Southampton, , United Kingdom

Countries

Australia; Canada; France; Germany; Spain; Switzerland; United Kingdom

References

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.

Reference Type: RESULT

PMID: 26069709 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24048551 (View on PubMed)

Other Identifiers

BST-CarGel Pr001

Identifier Type: -

Identifier Source: org_study_id