Direct Anterior Approach for Femoral Neck Fractures

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

October 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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.

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Direct Anterior Approach for Femoral Neck Fractures

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Direct anterior approach
total hip arthroplasty with DDA
Procedure: Direct Lateral Approach
total hip arthroplasty with DLA

Study Arms

Experimental: Direct anterior approach
total hip arthroplasty with direct anterior approach
Experimental: Direct Lateral Approach
total hip arthroplasty with direct lateral approach

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

130

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2022

Estimated Primary Completion Date

October 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Norway

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Helse Møre og Romsdal HF

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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