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Direct Anterior Approach for Femoral Neck Fractures

Sponsor
Helse Møre og Romsdal HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT03695497
Collaborator
St. Olavs Hospital (Other), Kristiansund Hospital (Other)
130
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Direct anterior approach
  • Procedure: Direct Lateral Approach
 N/A

Detailed Description

first included patient 23th November 2018

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Direct anterior approach

total hip arthroplasty with direct anterior approach

Procedure: Direct anterior approach
total hip arthroplasty with DDA
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Time Up and Go Test (TUG) [2,6,12 weeks, and 1 year]

    2. Change in Forgotten Joint Score for hip (FJS-12) [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.

    3. Change in Oxford Hip Score (OHS) [2,6,12 weeks, and 1 year]

      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).

    Secondary Outcome Measures

    1. Change in EQ-5D-5L score [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' 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kristiansund Hospital Kristiansund Norway

    Sponsors and Collaborators

    • Helse Møre og Romsdal HF
    • St. Olavs Hospital
    • Kristiansund Hospital

    Investigators

    • Study Chair: Øystein B Lian, md phd, Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helse Møre og Romsdal HF
    ClinicalTrials.gov Identifier:
    NCT03695497
    Other Study ID Numbers:
    • 2018/935
    First Posted:
    Oct 4, 2018
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Helse Møre og Romsdal HF
    Arthroplasty, Replacement, Hip
    Orthopedic procedures
    Additional relevant MeSH terms:
    Fractures, Bone
    Femoral Neck Fractures

    Study Results

    No Results Posted as of Jul 15, 2022