Actively Recruiting
Randomized Clinical Trial Comparing Intramedullary Nail and Hip Arthroplasty for Unstable Trochanteric Hip Fractures Survival, Complications, and Patient Reported Outcomes
Led by Helse Stavanger HF · Updated on 2026-04-30
170
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of surgeries for patients aged 65 and older who have unstable trochanteric hip fractures, a serious injury common in older adults that often leads to pain, decreased mobility, and increased risk of death. The study aims to see if hip arthroplasty improves mobility, overall health, quality of life, and reduces the need for additional surgeries compared to the traditional intramedullary nail treatment. This trial will help determine the best approach to treat these complex fractures, which currently have high complication and re-operation rates. Participants will be randomly assigned to receive either an intramedullary nail or hip arthroplasty. The intramedullary nail group will have a procedure involving a long nail inserted into the femur and may include additional fixation methods if needed. The hip arthroplasty group will undergo either hemiarthroplasty or total hip arthroplasty using specific prosthetic components, with surgery performed by experienced orthopedic surgeons. Both techniques follow detailed surgical protocols to ensure proper treatment of the unstable fractures. Throughout the study, patients will be followed up at 2, 6, and 12 months after surgery to assess their recovery. Evaluations include patient-reported outcome measures, physical tests such as the timed up and go test and Trendelenburg test, clinical assessments of leg length difference, and hip X-rays to monitor implant positioning and bone healing. The research team will collect data on complications, reoperations, and mortality to compare the effectiveness and safety of each treatment over time.
CONDITIONS
Brief Title
Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- American Society of Anesthesiology Score (ASA) less than 4
- Able to walk before injury, with or without assistance
- Radiologically confirmed unstable trochanteric hip fracture (AO 31A2.2 - 3.3)
- Written consent obtained from patient or next of kin
You will not qualify if you...
- Previous hip surgery on either hip
- Unable to walk before injury
- Not living in the hospital's care area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgery with either an intramedullary nail or hip arthroplasty to treat unstable trochanteric hip fractures.
1 surgical visit (in-person)
Duration - 12 months
Participants have follow-up appointments to assess patient-reported outcomes, clinical tests, and radiological evaluations after surgery.
3 visits at approximately 2, 6, and 12 months post-surgery (in-person)
Trial Site Locations
Total: 1 location
1
Stavanger University Hospital
Stavanger, Norway
Actively Recruiting
Research Team
T
Thomas Abel Woldeyesus, MD
A
Ane Djuv, MD., PhD
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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