The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Recruitment for this clinical trial complete.   Updates will be made  to this page when the study completes data analysis and results become available. Please check back often and find out how these studies have contributed to generating new knowledge about diseases and conditions within the NIAMS mission area.

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Study Description

Hip fractures occur in 280,000 Americans, over 5,000 per week. During the next 40 years, the number of hip fractures is likely to exceed 500,000 annually, and the estimated annual health care costs will reach a Staggering $9.8 billion. Hip fracture patients are at risk of a 30% mortality rate and impairment of independence and quality of life. Hip fractures are commonly treated with hip replacement, or arthroplasty. Two common types of arthroplasty exist, total hip arthroplasty (THA) and hemi-arthroplasty (HA). Advocates of hemi-arthroplasty (HA) focus upon reduced dislocation rates, lower rates of deep vein thrombosis, shorter operating times, less blood loss, and a technically less demanding procedure. Surgeons supporting THA perceive benefits in improving patient function and improving quality of life. Methodological limitations of previous studies, as well as their small sample sizes and resulting wide confidence intervals, have left the optimal operative approach unresolved.

 

Objectives: In patients over 50 years who have sustained a displaced femoral neck fracture, what is the rate of re-operation at 2 years when THA versus HA is used as the surgical treatment? This study will also evaluate patient function and quality of life. This study will recruit 100 more patients across 12 US sites and continue to follow the 100 patients from the pilot study. Patients will be randomized to either THA or HA and treated by surgeons with expertise in that technique. The study team will independently adjudicate revision surgery rates and collect functional outcome data at hospital discharge, 1 week, 10 weeks, 6-, 9-, 12-, 18- and 24-months. Hypothesis: the study hypothesizes that total hip arthroplasty will have similar or lower rates of re-operation (primary outcome) and higher functional outcome scores (secondary outcome) at 24 months compared with hemi-arthroplasty. This trial will not only change current orthopaedic practice but will set a benchmark for the conduct of future orthopaedic trials.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           50 Years and older (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  • Adult men or women aged 50 years and old (with no upper age limit)
  • Fracture of the femoral neck, as confirmed with either anteroposterior or lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI)
  • Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by reduction and internal fixation
  • Operative treatment is planned within 72 hours of the patient being medically cleared for surgery
  • Patient was ambulatory prior to the fracture, though they may have used an aid such as a cane or a walker
  • Anticipated medical optimization for arthroplasty of the hip
  • Provision of informed consent by patient or proxy
  • Low energy fracture (defined as a fall from standing height), with no other trauma
  • Assurance from site that surgeons with expertise in both total hip arthroplasty and hemi-arthroplasty are available to perform surgery (Note: Surgeons do not need to be experts in both techniques)
     

Exclusion Criteria:

  • Not suitable for hemi-arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures (secondary to cancer), or severe osteoarthritis of the hip)
  • Associated major injuries of the lower extremity (e.g., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture)
  • Retained hardware around the affected hip that will interfere with arthroplasty
  • Infection around the hip (soft tissue or bone)
  • Bone metabolism disorder except osteoporosis (e.g., Paget's disease, renal osteodystrophy, osteomalacia)
  • Patients with a previous history of frank dementia that would interfere with the assessment of primary outcome (e.g., secondary procedures at 2 years).
  • Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., no fixed address, plans to move out of town in the next year, or intellectually challenged and without adequate family support)
  • Enrolled in another ongoing drug or surgical intervention trial
  • Patients whose fracture occurred as a result of violence.

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Study Location(s):

New York University Medical Center, New York, New York, United States, 10003

McMaster University, Hamilton, Ontario, Canada, L8S4L8

Study Website:

https://clinicaltrials.gov/ct2/show/NCT00556842?term=NCT00556842&draw=2&rank=1

 

Last Updated: March 2020