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: Completed
• 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 (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kristiansund, Norway
    • Kristiansund Hospital

Participation Criteria

Eligibility Criteria

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

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
• Patients with an underlying illness that doesn't have life expectancy beyond six months
• In case of severe cognitive impairment where the patients are not able to give their informed consent

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
Difference in Timed Up and Go Test (TUG) between the groups	It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	6 weeks postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiological results 1.	We will look at the offset of the hip prosthesis.	postoperative, 3,12 months.
radiological results 2.	We will look at alignment of the stem. Femoral component angulation between 3° varus and 3° valgus relative to the femoral shaft axis will be considered neutral. Positioning outside this references will be graded as varus or valgus	postoperative, 3,12 months.
radiological results 3.	We will look at quality of stem cementation by Barrack	postoperative, 3,12 months.
radiological results 4.	We will look at leg length. It will be measured using the vertical height from the interteardrop line.	postoperative, 3,12 months.
radiological results 5.	We will look at inclination of the cup.It will be measured in reference to the interteardrop line.	postoperative, 3,12 months.
radiological results 6.	We will look at anteversion of the cup. It will be measured using the ischiolateral method.	postoperative, 3,12 months.
complications	periprosthetic fractures, dislocation, implant failure, neurovascular injury, infection. abductor failure, neurapraxia of LFCN), and mortality	Within the first year postoperatively.
Difference in Forgotten Joint Score for hip (FJS-12) between the groups	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
Difference in EQ-5D-5L score between the groups	5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233'. As there is no Norwegian index, the EQ5D-5L was converted into a Swedish index score.	2,6,12 weeks, and 1 year
Difference in Oxford Hip Score (OHS) between the groups	12 questions. Every question is scored 4 to 0 according to the selected response. Thus the highest score on 48 means a perfectly functioning hip, while a score on 0 means the worst outcome.	2,6,12 weeks, and 1 year
Difference in Timed Up and Go Test (TUG) between the groups	It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down	2,12 weeks, 1 year.
Difference in EQ5D-VAS between the groups	Respondents report their perceived health status with a grade ranging from 0 (worst possible health status) to 100 (best possible health status).	2,6,12 weeks, and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CK (Creatine Kinase)	Measure CK preoperatively and the first 4 postoperative days.	preoperatively and day 1,2,3,4 postoperatively.
Change in CRP (C-Reactive Protein)	Measure CRP preoperatively and the first 4 postoperative days.	preoperatively and day 1,2,3,4 postoperatively.
Change in Hb (Hemoglobin)-levels.	Measure Hb preoperatively and the first 4 postoperative days.	preoperatively and day 1,2,3,4 postoperatively.

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 (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

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 (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No