Non-union of Fractures Clinical Trial
Official title:
Autologous Stem Cell Therapy for Fracture Non-union Healing
Verified date | June 2014 |
Source | Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
Status | Completed |
Enrollment | 35 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 76 Years |
Eligibility |
Inclusion Criteria: - An established non-union according to the US Food & Drug Administration criteria14. - Non-union following fracture of tibia or femur suitable for synthetic bone grafting. Exclusion Criteria: 1. Skeletal immaturity. 2. Pregnant or breast-feeding. 3. Non-union following pathological fractures. 4. Positive to Hepatitis B, Hepatitis-C or HIV. 5. Infection during BMSC culture. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Robert Jones & Agnes Hunt Orthopaedic Hospital | Oswestry | Shropshire |
Lead Sponsor | Collaborator |
---|---|
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust | Keele University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | |
Secondary | EQ-5D | Change in EQ-5D index at 1 year was used as secondary outcome measures. | 12 months |