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. 2020 Feb 10;10(2):e032640. doi: 10.1136/bmjopen-2019-032640

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.