A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study

Helse Møre og Romsdal HF1 site in 1 country130 target enrollmentOctober 1, 2018

ConditionsFemoral Neck Fractures

Overview

Phase: N/A
Intervention: Not specified
Conditions: Femoral Neck Fractures
Sponsor: Helse Møre og Romsdal HF
Enrollment: 130
Locations: 1
Primary Endpoint: Difference in Timed Up and Go Test (TUG) between the groups
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.

Detailed Description

first included patient 23th November 2018

Registry

clinicaltrials.gov

Start Date

October 1, 2018

End Date

December 15, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Helse Møre og Romsdal HF

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Dislocated femoral neck fracture

Exclusion Criteria

•Infection around the hip (soft tissue or bone)
•Pathologic fracture
•Excessive alcohol or substance abuse that most likely will give reduced compliance
•Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
•Bedridden patients/non-walkers
•Patients with an underlying illness that doesn't have life expectancy beyond six months
•In case of severe cognitive impairment where the patients are not able to give their informed consent

Outcomes

Primary Outcomes

Difference in Timed Up and Go Test (TUG) between the groups

Time Frame: 6 weeks postoperatively.

It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

Secondary Outcomes

Difference in Forgotten Joint Score for hip (FJS-12) between the groups(2,6,12 weeks, and 1 year)
Difference in EQ-5D-5L score between the groups(2,6,12 weeks, and 1 year)
Difference in Oxford Hip Score (OHS) between the groups(2,6,12 weeks, and 1 year)
Difference in Timed Up and Go Test (TUG) between the groups(2,12 weeks, 1 year.)
Difference in EQ5D-VAS between the groups(2,6,12 weeks, and 1 year)
radiological results 1.(postoperative, 3,12 months.)
radiological results 2.(postoperative, 3,12 months.)
radiological results 3.(postoperative, 3,12 months.)
radiological results 4.(postoperative, 3,12 months.)
radiological results 5.(postoperative, 3,12 months.)
radiological results 6.(postoperative, 3,12 months.)
complications(Within the first year postoperatively.)