NCT02981355: RECORD

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

Terminated Phase 4 Last updated 1 November 2018

What this trial tests

Phase 4 trial testing Microfracture treatment in Traumatic; Lesion in 5 participants. Terminated before completion.

Timeline

26 July 2017

Primary endpoint
6 March 2018

6 March 2018

Quick facts

Lead sponsor	Piramal Healthcare Canada Ltd
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	5
Start date	26 July 2017
Primary completion	6 March 2018
Estimated completion	6 March 2018
Sites	15 locations across France, United Kingdom, Germany, Canada, Switzerland, Australia, Spain

Drugs / interventions tested

• Microfracture treatment
• BST-CarGel

Conditions studied

• Traumatic; Lesion — all drugs for Traumatic; Lesion →
• Degenerative Lesion of Articular Cartilage of Knee — all drugs for Degenerative Lesion of Articular Cartilage of Knee →

Sponsor

Piramal Healthcare Canada Ltd

Who can join

Adults 18 to 55, any sex, with Traumatic; Lesion or Degenerative Lesion of Articular Cartilage of Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Concise Review: Biomimetic Functionalization of Biomaterials to Stimulate the Endogenous Healing Process of Cartilage and Bone Tissue.
   Taraballi F, Bauza G, McCulloch P, Harris J, et al · · 2017 · cited 29× · PMID 29080279 · DOI 10.1002/sctm.17-0181