Fixation using Alternative Implants for the Treatment of Hip Fractures.

Completed

Conditions: Femoral neck fracture.

Registration Number: NL-OMON25279

Lead Sponsor: IHFRC (www.ihfrc.ca)Stichting Nuts-Ohra

Brief Summary: Zielinski SM, Bouwmans CAM, Heetveld MJ, Bhandari M, Patka P, Van Lieshout EMM, on behalf of the FAITH trial investigators. The societal costs of femoral neck fracture patients treated with internal fixation. Osteoporos Int. 2014 Mar;25(3):875-885. Zielinski SM, Viveiros H, Heetveld MJ, Swiontkowski MF, Bhandari M, Patka P, Van Lieshout EMM, on behalf of the FAITH trial investigators. Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience. Trials 2012;13(1):5. Zielinski SM, Meeuwis MA, Heetveld MJ, Verhofstad MHJ, Roukema GR, Patka P, Van Lieshout EMM. Adherence to a femoral neck fracture treatment guideline. Int Orthop 2013 Jul;37(7):1327-1334 Zielinski SM, Keijsers NL, Praet NFE, Heetveld MJ, Bhandari M, Wilssens JP, Patka P, Van Lieshout EMM, on behalf of the FAITH trial investigators. Femoral Neck Shortening After Internal Fixation of a Femoral Neck Fracture. Orthopedics 2013 Jul 1;36(7):e849-e858. Zielinski SM, Heetveld MJ, Bhandari M, Patka P, Van Lieshout EMM, FAITH trial investigators. Implant Removal After Internal Fixation of a Femoral Neck Fracture: Effects on Physical Functioning. J Orthop Trauma 2015 Sep;29(9):e285-e292.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

1. Adult men or women aged 50 years and older (with no upper age limit);

2. Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs or computed tomography, or magnetic resonance imaging;

Exclusion Criteria

1. Patinet not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, pathologic fracture);

2. Associated injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the femoral shaft, tibia, or foot, femoral head defects or fracture, or hip dislocation);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the impact of sliding hip screws versus cannulated screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures.

Secondary Outcome Measures

Name	Time	Method
We secondarily aim to determine the impact on health-related quality of life (Short Form-12, SF-12), functional outcomes (Western Ontario McMaster Osteoarthritis Index, WOMAC), and health utility (EQ5D).