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Direct Anterior Approach for Femoral Neck Fractures

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ClinicalTrials.gov Identifier: NCT03695497
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborators:
St. Olavs Hospital
Kristiansund Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: Direct anterior approach Procedure: Direct Lateral Approach Not Applicable

Detailed Description:
first included patient 23th November 2018

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Direct anterior approach
total hip arthroplasty with direct anterior approach
Procedure: Direct anterior approach
total hip arthroplasty with DDA
Other Name: DAA

Experimental: Direct Lateral Approach
total hip arthroplasty with direct lateral approach
Procedure: Direct Lateral Approach
total hip arthroplasty with DLA
Other Name: DLA




Primary Outcome Measures :
  1. Change in Time Up and Go Test (TUG) [ Time Frame: 2,6,12 weeks, and 1 year ]
  2. Change in Forgotten Joint Score for hip (FJS-12) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695497


Contacts
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Contact: John Magne Hoseth, md +47 71120000 john.magne.hoseth@helse-mr.no
Contact: Otto Schnell Husby, md phd

Locations
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Norway
Kristiansund Hospital Recruiting
Kristiansund, Norway
Contact: John Magne Hoseth, MD    +47 71120000    john.magne.hoseth@helse-mr.no   
Sponsors and Collaborators
Helse Møre og Romsdal HF
St. Olavs Hospital
Kristiansund Hospital
Investigators
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Study Chair: Øystein B Lian, md phd Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital

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Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03695497     History of Changes
Other Study ID Numbers: 2018/935
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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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:
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Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries