Direct Anterior Approach for Femoral Neck Fractures

Helse Møre og Romsdal HF130 enrolled

Overview

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.

first included patient 23th November 2018

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Femoral Neck Fractures

Interventions

Direct anterior approachPROCEDURE

total hip arthroplasty with DAA

Direct Lateral ApproachPROCEDURE

total hip arthroplasty with DLA

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Kristiansund Hospital

Kristiansund, Norway

Outcomes

Primary Outcomes

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

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.

Time frame: 6 weeks postoperatively.

Secondary Outcomes

Difference in Forgotten Joint Score for hip (FJS-12) between the groups

12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.

Time frame: 2,6,12 weeks, and 1 year

Difference in EQ-5D-5L score between the groups

5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233'. As there is no Norwegian index, the EQ5D-5L was converted into a Swedish index score.

Time frame: 2,6,12 weeks, and 1 year

Difference in Oxford Hip Score (OHS) between the groups

12 questions. Every question is scored 4 to 0 according to the selected response. Thus the highest score on 48 means a perfectly functioning hip, while a score on 0 means the worst outcome.

Time frame: 2,6,12 weeks, and 1 year

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

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

Time frame: 2,12 weeks, 1 year.

Difference in EQ5D-VAS between the groups

Respondents report their perceived health status with a grade ranging from 0 (worst possible health status) to 100 (best possible health status).

Data from ClinicalTrials.gov

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