Direct Anterior Approach for Femoral Neck Fractures

NCT03695497 | Completed DMC

• 1 other identifier: 2018/935
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures

Keywords

Arthroplasty, Replacement, Hip; Orthopedic procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks postoperatively.

Secondary Outcomes (12)

• 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

Other Outcomes (3)

• Change in CK (Creatine Kinase)

  preoperatively and day 1,2,3,4 postoperatively.

• Change in CRP (C-Reactive Protein)

  preoperatively and day 1,2,3,4 postoperatively.

• Change in Hb (Hemoglobin)-levels.

  preoperatively and day 1,2,3,4 postoperatively.

Study Arms (2)

Direct anterior approach

EXPERIMENTAL

total hip arthroplasty with direct anterior approach

Procedure: Direct anterior approach

Direct Lateral Approach

EXPERIMENTAL

total hip arthroplasty with direct lateral approach

Procedure: Direct Lateral Approach

Interventions

Direct anterior approach PROCEDURE

total hip arthroplasty with DAA

Also known as: DAA

Direct anterior approach

Direct Lateral Approach PROCEDURE

total hip arthroplasty with DLA

Also known as: DLA

Direct Lateral Approach

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dislocated femoral neck fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• St. Olavs Hospital: collaborator
• Kristiansund Hospital: collaborator

Study Sites (1)

Kristiansund Hospital

Kristiansund, Norway

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Øystein B Lian, md phd

  Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: October 1, 2018
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)