Tibial nonunion fractures Musculoskeletal Diseases Disorders of continuity of bone
Conditions
Interventions
The standard treatment involves microdrilling holes across the docking site into which the patients own bone marrow is injected. This will be the treatment in the control arm of the trial. The study i
Sponsors
Joint UCLH and UCL Biomedical Research Unit (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Imaging-based: 1. X-Rays: bridging of 3 out of 4 cortices 2. Finite Element Analysis (FEA) 3. Reliable Unwrapping Susceptibility Technique (RUST) scores 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. Clinical outcomes: 4. Short-form Musculoskeletal Function Assessment (SMFA) 5. Pain (Visual Analogue Scale [VAS]) 6. Quality of life (36-item Short Form Health Survey [SF36]) and the need for re-operation 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. | — |
Countries
United Kingdom
Outcome results
None listed