Actively Recruiting
Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture
Led by Uppsala University · Updated on 2024-12-03
340
Participants Needed
1
Research Sites
323 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aim To investigate the effect of internal fixation versus hip arthroplasty on physical function and pain in elderly patients. Methods This is a substudy of an on-going nationwide multicenter registry-based RCT named HipSTHeR- (Hip Screws or Total Hip replacement or undisplaced femoral neck fracture in elderly patients) \[21\]. The aim is to recruit 340 patients with undisplaced or minimally displaced femoral neck fracture, Garden 1 or 2, are randomized to surgery either with internal screw fixation or hip arthroplasty. This substudy aims to investigate the potential differences between internal fixation versus hip arthroplasty regarding physical function and pain 4- and 12- months after surgery. Those included in the main study will be contacted by letter a few weeks after the surgery to be invited to participate in a further study. The assessor will then contact the person by telephone to answer further questions and to obtain informed consent. The follow-ups will be conducted over telephone and mail at 4 and 12 months. During the follow-up the participants will answer questions about their functional level. Information on randomisation and fracture data will be acquired from the Swedish Fracture Register and treatment data from the Swedish Hip Arthroplasty Register. Primary outcome The New Mobility Score will be used as the primary outcome with follow-up at 4- and 12 months. Secondary outcome WOMAC will be used as an additional hip specific patient reported outcome. Activities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL. Patients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE). The Geriatric Depression Scale (GDS-15), which are developed to identify depressive symptoms. The Philadelphia Geriatric Center Morale Scale (PGCMS) and have been used in several studies including frail people living in residential care facilities and can be used among patients with cognitive impairment.
CONDITIONS
Official Title
Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undisplaced (Garden I-II) femoral neck fracture within 72 hours
- Treated at a participating study center
- Able to provide informed consent
- Eligible for both internal fixation and hip arthroplasty treatments
- Included in the HipSTHeR trial
You will not qualify if you...
- Unable to provide informed consent
- Pathological or stress fractures
- Peri-implant femoral neck fracture
- Previously included with a contralateral Garden I or II femoral neck fracture
AI-Screening
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Trial Site Locations
Total: 1 location
1
Olof Wolf
Uppsala, Sweden
Actively Recruiting
Research Team
S
Sebastian Mukka, MD, PhD
CONTACT
E
Erika Olofsson, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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