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: Completed

Administrative data

• NCT number: NCT03695497
• Other study ID #: 2018/935
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2024
• Source: Helse Møre og Romsdal HF
• Contact: n/a
• 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: Completed
• Enrollment: 130
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• 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

• 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

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
Other	Change in CK (Creatine Kinase)	Measure CK preoperatively and the first 4 postoperative days.	preoperatively and day 1,2,3,4 postoperatively.
Other	Change in CRP (C-Reactive Protein)	Measure CRP preoperatively and the first 4 postoperative days.	preoperatively and day 1,2,3,4 postoperatively.
Other	Change in Hb (Hemoglobin)-levels.	Measure Hb preoperatively and the first 4 postoperative days.	preoperatively and day 1,2,3,4 postoperatively.
Primary	Change in Timed Up and Go Test (TUG)	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	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
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'. As there is no Norwegian index, the EQ5D-5L was converted into a Swedish index score.	2,6,12 weeks, and 1 year
Secondary	Change in Oxford Hip Score (OHS)	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
Secondary	Change in Timed Up and Go Test (TUG)	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.
Secondary	EQ5D-VAS	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
Secondary	radiological results 1.	We will look at the offset of the hip prosthesis.	postoperative, 3,12 months.
Secondary	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.
Secondary	radiological results 3.	We will look at quality of stem cementation by Barrack	postoperative, 3,12 months.
Secondary	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.
Secondary	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.
Secondary	radiological results 6.	We will look at anteversion of the cup. It will be measured using the ischiolateral method.	postoperative, 3,12 months.
Secondary	complications	periprosthetic fractures, dislocation, implant failure, neurovascular injury, infection. abductor failure, neurapraxia of LFCN), and mortality	Within the first year postoperatively.