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

NCT02981355 | Terminated Phase 4 DMC

• 1 other identifier: BST-CarGel Pr001
• Study Type: interventional
• Target: 5
• Locations: 7 countries
• Sites: 15

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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).

  Baseline to 24 months post-surgery

• 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.

  Baseline to 24 months post-surgery

• 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.

  Baseline to 24 months post-surgery

• 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.

  Baseline to 24 months post-surgery

Secondary Outcomes (3)

• Repair tissue quantity and quality

  Up to 24 months post-surgery

• Adverse events related to treatment

  Up to 24 months post-surgery

• Economic evaluation

  surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery

Study Arms (2)

Microfracture treatment

ACTIVE COMPARATOR

Microfracture surgery of the femoral condyle

Procedure: Microfracture treatment

BST-CarGel plus microfracture treatment

EXPERIMENTAL

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; Device: BST-CarGel

Interventions

Microfracture treatment PROCEDURE

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

BST-CarGel plus microfracture treatment; Microfracture treatment

BST-CarGel 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.

BST-CarGel plus microfracture treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Piramal Healthcare Canada Ltd: lead
• Smith & Nephew, Inc.: collaborator
• Global Research Solutions: collaborator

Study Sites (15)

Calvary Wakefield Hospital

Adelaide, 5000, Australia

Location

Murdoch Orthopaedic Clinic

Murdoch, 6150, Australia

Location

Banff Sport Medicine

Banff, T1L1B3, Canada

Location

Fowler Kennedy Sport Medicine Clinic

London, N6A3K7, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, H1T4B3, Canada

Location

Hopital de La Croix-Rousse

Lyon, 69004, France

Location

CHRU Nancy - Hospital Central

Nancy, 54000, France

Location

University Medical Centre Regensburg

Regensburg, 93042, Germany

Location

Hospital Universitari del Mar

Barcelona, 08003, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

SportClinic Zurich / Hirslanden Clinic

Zurich, 8032, Switzerland

Location

The Royal Orthopaedic Hospital

Birmingham, B312AP, United Kingdom

Location

University Hospital Southampton

Southampton, S0166YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 26069709 RESULT

• 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.

  PMID: 24048551 RESULT

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Jean-Pierre Desmarais

  Piramal Healthcare Canada Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 5, 2016
• Study Start: July 26, 2017
• Primary Completion: March 6, 2018
• Study Completion: March 6, 2018
• Last Updated: November 1, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); FR (2); DE (1); CA (3); ES (4); AU (2); CH (1)