Clinical trial NCT03695497: Direct Anterior Approach for Femoral Neck Fractures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Arthroplasty, Replacement, Hip
Orthopedic procedures
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: St. Olavs Hospital
name: Kristiansund Hospital
First posted: 2018-10-04
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: first included patient 23th November 2018

Eligibility 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
* 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

Primary outcomes:
measure: Difference in Timed Up and Go Test (TUG) between the groups
timeFrame: 6 weeks postoperatively.
Secondary outcomes:
measure: Difference in Forgotten Joint Score for hip (FJS-12) between the groups
timeFrame: 2,6,12 weeks, and 1 year
measure: Difference in EQ-5D-5L score between the groups
timeFrame: 2,6,12 weeks, and 1 year
measure: Difference in Oxford Hip Score (OHS) between the groups
timeFrame: 2,6,12 weeks, and 1 year
measure: Difference in Timed Up and Go Test (TUG) between the groups
timeFrame: 2,12 weeks, 1 year.
measure: Difference in EQ5D-VAS between the groups
timeFrame: 2,6,12 weeks, and 1 year
measure: radiological results 1.
timeFrame: postoperative, 3,12 months.
measure: radiological results 2.
timeFrame: postoperative, 3,12 months.
measure: radiological results 3.
timeFrame: postoperative, 3,12 months.
measure: radiological results 4.
timeFrame: postoperative, 3,12 months.
measure: radiological results 5.
timeFrame: postoperative, 3,12 months.
measure: radiological results 6.
timeFrame: postoperative, 3,12 months.
measure: complications
timeFrame: Within the first year postoperatively.
Other outcomes:
measure: Change in CK (Creatine Kinase)
timeFrame: preoperatively and day 1,2,3,4 postoperatively.
measure: Change in CRP (C-Reactive Protein)
timeFrame: preoperatively and day 1,2,3,4 postoperatively.
measure: Change in Hb (Hemoglobin)-levels.
timeFrame: preoperatively and day 1,2,3,4 postoperatively.
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Hospital
Study officials:
affiliation: Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital
name: Øystein B Lian, md phd
role: STUDY_CHAIR
References: