Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures (HEALTH)
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|ClinicalTrials.gov Identifier: NCT00556842|
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures Femoral Neck Fractures||Device: Total hip arthroplasty Device: Hemi-arthroplasty||Not Applicable|
One type of hip fracture, called a femoral neck fracture, involves a break in the narrow part of the femur bone where the head of the femur is joined to the main shaft. The break can be either undisplaced, which involves very little separation at the fracture site, or displaced, in which there is substantial separation. For displaced fractures, surgeons usually choose between internal fixation and hip arthroplasty, which is also known as hip replacement.
Patients receiving hip arthroplasty may undergo either a total hip arthroplasty or a hemi-arthroplasty. Which surgical method is best for the patient is unknown. Advocates of total hip replacement claim better improvements in patient function and quality of life. On the other hand, advocates of hemi-arthroplasty, which include most orthopaedic surgeons, claim reduced rates of dislocation and deep vein thrombosis, shorter operating times, less blood loss, and a technically less demanding surgical procedure. This study will compare total hip arthroplasty and hemi-arthroplasty on rates of revision surgery 2 years after patients aged 50 and older sustain femoral neck fractures and undergo surgery. The study will also compare the impact of the two different surgical procedures on function, quality of life, and post-surgical complications. Results from this study may impact current orthopaedic practice.
Participation in this study will last 2 years. Before surgery, participants will complete a baseline assessment that will include x-rays, a medical history review, and a physical examination. Participants will then be randomly assigned to undergo either total hip arthroplasty or hemi-arthroplasty to repair their hip fractures. All surgeons will need to meet certain criteria to partake in the study and will have expertise in whichever surgical procedure they are performing. Surgeons will also follow the manufacturers' implant guidelines during surgery. Specific aspects of both the preoperative and post-operative care, such as weight bearing status, the prevention of thromboembolic disease, and the use of antibiotics and calcium supplementation, will be standardized for all participants. Within 2 days of under going surgery, x-rays will be performed again.
Follow-up assessments will be completed either by phone or in-person at the hospital or clinic. They will occur 1 and 10 weeks after surgery and 6, 9, 12, 18, and 24 months after surgery. All assessments will include questionnaires and interviews on health status, hip function, pain, functional mobility, and revision surgery. Some of the in-person assessments will also include x-rays.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1495 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||May 30, 2019|
|Actual Study Completion Date :||May 30, 2019|
Active Comparator: 1
Participants will undergo total hip arthroplasty.
Device: Total hip arthroplasty
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.
Other Name: THA
Active Comparator: 2
Participants will undergo hemi-arthroplasty.
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.
Other Name: HA
- Number of Participants With Revision Surgery [ Time Frame: Measured 2 years after original surgery ]The primary outcome is any unplanned secondary procedure within 2 years of the initial joint replacement surgery.
- Hip Function and Pain [ Time Frame: Measured 2 years after original surgery ]Hip function and pain were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a self-administered questionnaire that assesses 3 dimensions of pain, disability, joint stiffness in knee and hip osteoarthritis. This questionnaire uses a Likert scale, with the responses: none, mild, moderate, severe, and extreme. A higher score indicates worse pain, stiffness, and functional limitations. The ranges are: 0-20 for pain, 0-8 for stiffness, 0-68 for physical function. The sum of the pain, stiffness, and physical function subscales provides the WOMAC total score, which ranges from 0-96.
- Number of Participants With Functional Mobility Problems [ Time Frame: Measured 2 years after original surgery ]
Functional outcome measured using the Timed Up and Go (TUG) test. The TUG test is a standardized, physical test to assess balance and mobility in the participants. The participant is timed while they perform simple physical movements, such as rising from an arm chair, walking 10 feet, walking back to the chair, and sitting down. A faster time indicates that the participant has greater functional performance, while a lower score may identify participants who are at risk for increased falls in the community.
We analyzed the TUG as a dichotomous outcome with the following categories: a) patients who complete the test in ≤12 seconds, and b) those who require >12 seconds to complete the test or were unable to complete the test. We selected 12 seconds as the cut-off because this was the threshold used by the Centers for Disease Control and Prevention. We report the number of participants in each group who required >12 seconds to complete the test or were unable to complete the test
- Health-Related Quality of Life (SF-12) [ Time Frame: Measured 2 years after original surgery ]Health-related quality of life measured using the SF-12 Health Survey, which is a standardized instrument to measure health- related quality of life. This self-administered, 12-item questionnaire covers eight main health domains that make up the Physical and Mental Health Composite Scores (PCS & MCS). Each domain consists of one or two questions and is scored separately from 0 (lowest level) to 100 (highest level). Higher scores represent better health-related quality of life.
- Health-Related Quality of Life (EQ-5D) [ Time Frame: Measured 2 years after original surgery ]
Health-related quality of life was measured using the EQ-5D, which is a standardized instrument that comprises of a short descriptive system questionnaire and a visual analogue scale (EQ-5D VAS).
The questionnaire provides a simple descriptive profile of a respondent's health state. When the descriptive system profile is linked to a 'value set', a single summary index value for health status on a 0 to 1 scale is derived that can be used in economic evaluations of healthcare interventions. A health utility value of 1 indicates perfect health while a score of 0 indicates death.
The EQ-5D VAS assesses the individual's health today on a scale from 0-100, with the 0 being 'worst imaginable state of health' and 100 being 'best imaginable state of health'.
- Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening [ Time Frame: Measured 2 years after original surgery ]Hip-related complications including peri-prosthetic fracture, hip instability or dislocation, implant failure (loosening/subsidence and breakage), would healing problems (including superficial/deep infection, wound necrosis), soft tissue problems (e.g. pseudotumor), heterotopic ossification, abductor failure, implant wear and corrosion, osteolysis, neurovascular injury, decreased function, or pain. Measured at 1 and 10 weeks, 6, 9,12, 18, 24 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556842
|United States, New York|
|New York University Medical Center|
|New York, New York, United States, 10003|
|Hamilton, Ontario, Canada, L8S4L8|
|Principal Investigator:||Mohit Bhandari, MD PhD FRCSC||McMaster University|
|Principal Investigator:||Thomas A. Eihnorn, MD||Boston University|