The Hip Fracture Surgical Approach Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Fracture
- Sponsor
- Diakonhjemmet Hospital
- Enrollment
- 406
- Locations
- 1
- Primary Endpoint
- Harris Hip Score ( HHS)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.
Detailed Description
Femoral neck fractures are mostly treated with a hemiarthroplasty, where the fractured femoral head is replaced with a metal implant. The most common surgical approach to hemiarthroplasty has been the lateral approach, in which the gluteus medius tendon is partially released from the greater trochanter. Hip pain and limping is not uncommon after this approach has been used. A new surgical approach (SPAIRE) has been developed to alleviate this problem, and in this method the surgeon approaches the injured hip joint from posterior, preserving most of the muscles and tendons around the hip. This trial is designed to assess if this new SPAIRE approach leads to better results than the lateral approach in patients with femoral neck fractures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Femoral neck fracture
- •Clinical indication for hemiarthroplasty
- •Age over 50 years
Exclusion Criteria
- •Previous hip implants in the same hip
- •Patients assessed to be in a terminal state with an expected survival of less than 1 week
- •Other factors that makes follow-up impossible
Outcomes
Primary Outcomes
Harris Hip Score ( HHS)
Time Frame: 4 months
Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).
Secondary Outcomes
- Oxford Hip score(4,12 and 24 months)
- EuroQol-5d-5l(4,12 and 24 months)
- Trendelenburg test(4,12 and 24 months)
- Numerical Pain Rate Scale( NPRS)(4, 12 and 24 months)
- New Mobility Score (NMS)(4,12 and 24 months)
- Adverse events(0-24 months)
- Duration of surgery(1.st day after surgery)
- Preferred Walking Speed(4,12 and 24 months)
- Harris Hip Score (HHS)(12 and 24 months)
- Short Physical Performance Battery (SPPB)(4, 12, an 24 months)
- Repeated Chair Stand Test(4,12 and 24 months)
- Cumulated Ambulation Score(1-5 days after surgery)
- Timed up and go test(4,12 and 24 months)
- Use of analgesia during admission(1. day after surgery)
- Days Alive At Home (DAH)(4,12 and 24 months)