CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,495 enrolled
Drug / intervention
Total hip arthroplasty +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00556842
NCT00556842N/ACompleted

Hip Fracture Evaluation With Alternatives of Total Hip Arthroplasty Versus Hemi-Arthroplasty: A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients With Displaced Femoral Neck Fractures

McMaster University·interventional·Posted Nov 12, 2007·Updated Jul 7, 2020

In Brief

A clinical study evaluating Total hip arthroplasty and Hemi-arthroplasty for Hip Fractures and Femoral Neck Fractures. Completed, enrolled 1,495 participants across 2 sites in 2 countries.

Detailed Summary

Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare costs associated with hip fractures are expected to reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a displaced femoral neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip replacement may receive either a total hip replacement, in which the head of the femur and the hip joint socket are replaced, or a partial hip replacement, in which only the head of the femur is replaced. This study will compare the two different hip replacement procedures to determine which one results in better outcomes after surgery in adults aged 50 and older.

Study Details

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 12, 2007
Enrollment StartMar 1, 2009
Primary CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 10.2 yearsPosted 18.6 years ago

Interventions

Total hip arthroplastydevice

Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.

Hemi-arthroplastydevice

Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.