S72.1
Conditions
Interventions
Group 1: Single centre, prospective, randomised clinical trial at the University Medical Center Göttingen. Forty adult patients with AO 31 A1/A2 pertrochanteric femoral fractures will be randomly allo
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Male and female patients with a pertrochanteric femoral fracture AO 31 A1 or 31 A2. • Age = 18 years at the time of surgery. • Suitability for implantation of a standard Gamma nail of at least 235 mm length (per treating surgeon’s judgment and manufacturer’s instructions). • Patient has understood the nature and conditions of the study and has provided written informed consent before surgery.
Exclusion criteria
Exclusion criteria: • Multimorbid patients who, due to their comorbidities, cannot be operated on using the conventional Gamma nail method (e.g. anaesthetic risk prohibiting standard positioning/approach). • Patients with a pathological fracture (e.g. metastatic, primary bone tumour). • Patients who do not provide written informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tip–apex distance (TAD) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiation exposure (process endpoints) 2. Duration of locking of the intramedullary nail / operative stage times 3. Exploratory variables: o Comparison of the above parameters between cases operated by experienced vs less experienced surgeons. o Documentation of any complications attributable to use of ADAPT, and any technical problems (system malfunction, delays). | — |
Countries
Germany
Contacts
Public ContactWolfgang Lehmann
Klinik für Unfallchirurgie, Orthopädie und Plastische Chirurgie
Outcome results
None listed