Fixation Methods of Basicervical Fractures

NCT04240743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Hip Fractures
  • Osteoporotic Fractures

Interventions

DEVICE

cephalomedullary nail

For patients in the cephalomedullary nail group, an incision was made in the gluteal area from the tip of the greater trochanter in proximal orientation. A guidewire was placed into the medullary canal from slightly medial to the exact tip of the greater trochanter. The entry point of the greater trochanter and proximal medullary canal were reamed. The cephalomedullary nail was then inserted and fixed to the femoral head with a double screw. The cephalomedullary nail was then locked distally using a guide arm. These cephalomedullary nails were not locked proximally to maintain dynamization and to allow compression across the basicervical fracture line.

DEVICE

sliding hip screw

For patients in the sliding hip screw group, a lateral incision was made over the lateral proximal aspect of the femur. Under fluoroscopic guidance, the lag screw was placed centrally in the femoral head over the guidewire. A side plate with three holes was then attached to the hip screw.

Sponsors & Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2017-12-27
Completion
2018-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240743 on ClinicalTrials.gov