An interventional study of carrier plus in vitro expanded autologous BMSCs in Non-union of Fractures, sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Not applicable, Interventional, and Treatment
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 35 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust is the lead sponsor of 36 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
carrier plus in vitro expanded autologous BMSCs
Biological: carrier plus in vitro expanded autologous BMSCs
Carrier alone
Biological: carrier plus in vitro expanded autologous BMSCs
The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container
Radiological assessment of new callus and fracture bridging
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.
Time frame: 12 months
EQ-5D
Change in EQ-5D index at 1 year was used as secondary outcome measures.
Time frame: 12 months
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust