Clinical Trial: Autologous Stem Cell Therapy for Fracture Non-union Healing

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Autologous Stem Cell Therapy for Fracture Non-union Healing

Brief Summary: Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

Detailed Summary: Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.
Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Current Primary Outcome: Radiological assessment of new callus and fracture bridging [ Time Frame: 12 months ]

The primary outcome measure was formation of new callus and cortical bridging, assessed from pre-operative and multiple post-operative radiographs and CT-scans up to 12 months. These images were divided into early (0-3 months) and late (9-12 months) groups. Non-unions were assessed from anonymized slides by four independent reviewers (two radiologists and two orthopedic surgeons) blinded to the side of cell insertion. Each slide had a pre-operative radiograph for comparison but no indication of time since surgery, and showed a medial/ lateral or an anterior/ posterior view depending on the surgical approach . At first, each reviewer indicated the side with largest callus and most cortical bridging pre-operatively. Then each reviewer examined subsequent radiographs to indicate the side with the largest increase in new callus and cortical bridging.


Original Primary Outcome: Same as current

Current Secondary Outcome: EQ-5D [ Time Frame: 12 months ]

Change in EQ-5D index at 1 year was used as secondary outcome measures.


Original Secondary Outcome: Same as current

Information By: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Dates:
Date Received: June 20, 2014
Date Started: January 2000
Date Completion:
Last Updated: June 25, 2014
Last Verified: June 2014