Table 1.
Trial registration data
| Data category | Information |
| Primary registry and trial identifying number | https://www.anzctr.org.au, ACTRN12618001431213 |
| Date of registration in primary registry | 27/08/2018 |
| Secondary identifying numbers | None |
| Source of monetary or material support | Smith & Nephew Pty Ltd |
| Primary sponsor | Royal Adelaide Hospital, Department of Orthopaedics & Trauma Contact person: MR (mark.rickman@sa.gov.au) Smith & Nephew Inc Orthopaedic Division (SN) |
| Secondary sponsor | University of Adelaide, Centre for Orthopaedic & Trauma Research Contact person: AS (arjun.sivakumar@adelaide.edu.au) Contact person: DT (dominic.thewlis@adelaide.edu.au) |
| Contact for public queries | MR (mark.rickman@sa.gov.au) |
| Contact for scientific queries | DT (dominic.thewlis@adelaide.edu.au) |
| Public title | Evaluating the treatment methods of proximal femur fractures in elderly patients with trauma |
| Scientific title | A multicentre, single-blinded prospective RCT of the Gamma3 intramedullary nail to the unlocked and locked Intertan intramedullary nail for the treatment of proximal femur fractures |
| Countries of recruitment | Australia |
| Health problem studied | Proximal femur fracture |
| Interventions | Gamma3 trochanteric nail (unlocked proximally) Trigen Intertan Trochanteric nail (unlocked proximally) Trigen Intertan Trochanteric nail (locked proximally) |
| Key inclusion and exclusion criteria | Inclusion criteria: traumatic extracapsular hip fracture, closed injury, patient aged over 60 years, ability to be followed for up to 6 months, presentation to hospital within 14 days of injury Exclusion criteria: patients with concomitant injuries affecting treatment and rehabilitation of the affected limb, patients with associated neurovascular injuries requiring immediate surgery, patients where consent is refused, patients with limited English proficiency including family members |
| Study type | RCT |
| Date of first enrolment | 05/09/2018 |
| Target sample size | 900 |
| Recruitment status | Recruiting |
| Primary Outcome | Construct failure (time point: up to 6 months after intervention) |
| Key secondary outcomes | Incidence of Injury specific complications (time point: 6 months) Functional independence (time point: 6 months) Reoperation incidence (time point: 6 months) Return to mobility circumstances (time point: 6 months) Hip joint range of motion (time point: 6 months) Hip joint contact forces (time point: 6 months) Postoperative hip muscle function (abductors, flexors, extensors; time point: 6 months) |
RCT, randomised controlled trial.