Direct Anterior Approach for Femoral Neck Fractures

Femoral Neck Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695497
• Other study ID #: 2018/935
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 2024

Study information

• Verified date: January 2023
• Source: Helse Møre og Romsdal HF
• Contact: John Magne Hoseth, md
• Phone: +47 71120000
• Email: john.magne.hoseth[@]helse-mr.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

first included patient 23th November 2018

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Norway	Kristiansund Hospital	Kristiansund

Sponsors (3)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF	Kristiansund Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time Up and Go Test (TUG)		2,6,12 weeks, and 1 year
Primary	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
Primary	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	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