Direct Anterior Approach for Femoral Neck Fractures

Not Applicable

Completed

• Conditions: Femoral Neck Fractures
• Interventions: Procedure: Direct Lateral Approach; Procedure: Direct anterior approach

• Registration Number: NCT03695497
• Lead Sponsor: Helse Møre og Romsdal HF

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Dislocated femoral neck fracture

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Lateral Approach	Direct Lateral Approach	total hip arthroplasty with direct lateral approach
Direct anterior approach	Direct anterior approach	total hip arthroplasty with direct anterior approach

Primary Outcome Measures

Name	Time	Method
Difference in Timed Up and Go Test (TUG) between the groups	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 Outcome Measures

Name	Time	Method
Difference in Forgotten Joint Score for hip (FJS-12) between the groups	2,6,12 weeks, and 1 year	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.
Difference in EQ-5D-5L score between the groups	2,6,12 weeks, and 1 year	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.
Difference in Oxford Hip Score (OHS) between the groups	2,6,12 weeks, and 1 year	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.
Difference in Timed Up and Go Test (TUG) between the groups	2,12 weeks, 1 year.	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
Difference in EQ5D-VAS between the groups	2,6,12 weeks, and 1 year	Respondents report their perceived health status with a grade ranging from 0 (worst possible health status) to 100 (best possible health status).
radiological results 1.	postoperative, 3,12 months.	We will look at the offset of the hip prosthesis.
radiological results 2.	postoperative, 3,12 months.	We will look at alignment of the stem. Femoral component angulation between 3° varus and 3° valgus relative to the femoral shaft axis will be considered neutral. Positioning outside this references will be graded as varus or valgus
radiological results 3.	postoperative, 3,12 months.	We will look at quality of stem cementation by Barrack
radiological results 4.	postoperative, 3,12 months.	We will look at leg length. It will be measured using the vertical height from the interteardrop line.
radiological results 5.	postoperative, 3,12 months.	We will look at inclination of the cup.It will be measured in reference to the interteardrop line.
radiological results 6.	postoperative, 3,12 months.	We will look at anteversion of the cup. It will be measured using the ischiolateral method.
complications	Within the first year postoperatively.	periprosthetic fractures, dislocation, implant failure, neurovascular injury, infection. abductor failure, neurapraxia of LFCN), and mortality

Trial Locations

Locations (1)

Kristiansund Hospital; 🇳🇴 Kristiansund, Norway