Direct Anterior Approach for Femoral Neck Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Procedure: Direct Lateral Approach; Procedure: Direct anterior approach

Detailed Description

first included patient 23th November 2018

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Magne Hoseth, MD; Phone Number: +47 71120000; Email: john.magne.hoseth@helse-mr.no
• Study Contact Backup: Name: Otto Schnell Husby, md phd

Study Locations

• Norway
  • Kristiansund, Norway
    • Recruiting
    • Kristiansund Hospital
    • Contact: John Magne Hoseth, MD; Phone Number: +47 71120000; Email: john.magne.hoseth@helse-mr.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct anterior approach; total hip arthroplasty with direct anterior approach	Procedure: Direct anterior approach; total hip arthroplasty with DAA; Other Names: DAA
Experimental: Direct Lateral Approach; total hip arthroplasty with direct lateral approach	Procedure: Direct Lateral Approach; total hip arthroplasty with DLA; Other Names: DLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time Up and Go Test (TUG)		2,6,12 weeks, and 1 year
Change in Forgotten Joint Score for hip (FJS-12)	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.	2,6,12 weeks, and 1 year
Change in Oxford Hip Score (OHS)	12 questions. Every question is scored 4 to 0 according to the selected response. Thus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0).	2,6,12 weeks, and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EQ-5D-5L score	5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office	2,6,12 weeks, and 1 year

Collaborators and Investigators

• Sponsor: Helse Møre og Romsdal HF
• Collaborators: St. Olavs Hospital; Kristiansund Hospital
• Investigators: Study Chair: Øystein B Lian, md phd, Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Arthroplasty, Replacement, Hip; Orthopedic procedures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: 2018/935

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No