MedTrace Logo

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

NCT02981355 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-11-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • Global Research Solutions

    collaborator INDUSTRY

  • Piramal Healthcare Canada Ltd

    lead INDUSTRY

Principal Investigators

  • Jean-Pierre Desmarais · Piramal Healthcare Canada Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2018-03-06
Completion
2018-03-06

Countries

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

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981355 on ClinicalTrials.gov