Hip Fractures Clinical Trial
Official title:
Comparison of Intramedullary and Extramedullary Fixation of Basicervical Fractures of the Femur in the Elderly: a Prospective, Randomized Controlled Trial
This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. The patients were allocated to one of two groups treated via cephalomedullary nail (CMN) or sliding hip screw (SHS). Functional and radiological evaluations was included the mobility score, Harris hip score, modified Barthel index, the Singh index, the tip-apex distance, and fracture settling.
Approval for this prospective randomized study was granted by the Local Ethics Review Board
and all procedures were performed in accordance with the ethical standards of the Declaration
of Helsinki (1964). Patients with a basicervical femur fracture were identified on admission
to the Emergency Department of our tertiary hospital from January 2016 to January 2018.
Patients with scheduled surgery who met the inclusion criteria and provided written informed
consent were included in the study.
Patients were randomly allocated to a study group by permuted blocks of randomly mixed sizes
and stratification according to the type of surgery (CMN or SHS). Randomization was applied
using pre-prepared randomization cards, which were placed in opaque sealed envelopes and
given to the surgeons to open just prior to surgery, and the designated procedure was then
performed.
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