Fixation Methods of Basicervical Fractures

January 22, 2020 updated by: Huseyin Bilgehan Cevik, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cephalomedullary nail
Cephalomedullary nails was inserted and fixed to the femoral head. In this study, all patients were treated with short nails (Profin®, TST).
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.
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.
Active Comparator: sliding hip screw
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).
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mobility score
Time Frame: 12 months
Functional outcome was assessed by the mobility score of Parker and Palmer (Parker MJ, Palmer CR (1993) A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br 75: 797-798), which uses a nine-point scale.
12 months
Harris hip score
Time Frame: 12 months
Hip function was rated with Harris Hip Score. The score has a maximum of 100 points (best possible function), covering pain (1 item, 0-44 points), function and activities (7 items, 0-47 points), and range of motion and absence of deformity (3 items, 0-9 points).
12 months
modified Barthel index
Time Frame: 12 months
Barthel Index (Mahoney FI, Barthel DW (1965) Functional evaluation: the Barthel Index. A simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill. Md State Med J 13:61-65), which measures the level of functional independence for 10 activities of daily living and ranges from 0 to 100.
12 months
the tip-apex distance
Time Frame: 12 months
It uses a numerical value (the distance between tip of screw and subchondral area) to show placement of the screw in the head: higher values indicating higher likelihood of fixation failure by extrusion of the screw.
12 months
fracture settling
Time Frame: 12 months
It uses a numerical value to show placement of shortening of the fractured femoral neck in time
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 27, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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