sing autologous mesenchymal stem cells (MSC) to treat human fractures

Completed

Conditions: Tibial nonunion fractures
Musculoskeletal Diseases
Disorders of continuity of bone

Registration Number: ISRCTN09755245

Lead Sponsor: Joint UCLH and UCL Biomedical Research Unit (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Skeletally mature patients undergoing segmental excision of the tibia for nonunion followed by distraction osteogenesis and bone transport
2. Male and female patients
3. Over 18 years old with no upper age limit

Exclusion Criteria

1. Congenital disorders
2. Pregnant or lactating women
3. Metabolic bone disease or bone active drugs
4. Anticipated problems with maintaining follow-up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bone mineral content (BMC) in a defined region of interest (ROI) around the docking site between 0 - 12 weeks after implantation, derived from computed tomography (CT) scans.

Secondary Outcome Measures

Name	Time	Method
Imaging-based: <br>1. X-Rays: bridging of 3 out of 4 cortices <br>2. Finite Element Analysis (FEA) <br>3. Reliable Unwrapping Susceptibility Technique (RUST) scores <br><br>The first antero-posterior (AP) and lateral radiographs will be taken prior to the segmental excision and after enrolment and then at 2 weekly intervals for 12 weeks with 3 radiographs in addition to standard care and then in line with standard care until week 52. <br><br>Clinical outcomes: <br>4. Short-form Musculoskeletal Function Assessment (SMFA) <br>5. Pain (Visual Analogue Scale [VAS]) <br>6. Quality of life (36-item Short Form Health Survey [SF36]) and the need for re-operation <br><br>Patients will be asked to complete SF36 and SMFA questionnaires at 2, 12 and 25 weeks and VAS pain scores will be given in line with standard care.