Fixation Methods of Basicervical Fractures

Republic of Turkey Ministry of Health

Status: Completed

Conditions: Hip Fractures; Osteoporotic Fractures

Treatments: Device: cephalomedullary nail; Device: sliding hip screw

Study type: Interventional

Funder types: Other

Identifiers

NCT04240743

2015/514/74/7

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• basicervical fracture,
• age of ≥65 year,
• an isolated fracture,
• the ability to walk independently (with or without an aid) prior to fracture,
• a fracture that had occurred less than one week prior to admission.

Exclusion criteria

• history of ipsilateral femoral fracture,
• a fracture due to malignancy,
• limited life expectancy due to medical comorbidities,
• any contraindication to surgery,
• diagnosed dementia,
• any other traumatic fracture on admission.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 2 patient groups

cephalomedullary nail

Active Comparator group

Description:

Cephalomedullary nails was inserted and fixed to the femoral head. In this study, all patients were treated with short nails (Profin®, TST).

Treatment:

Device: cephalomedullary nail

Device: sliding hip screw

sliding hip screw

Active Comparator group

Description:

Sliding hip screws was inserted and fixed to the femoral head. In this study, all patients were treated with a side plate with three holes (DHS plate, TST).

Treatment:

Device: cephalomedullary nail

Device: sliding hip screw