Geriatric Acetabular FracTures: Open Reduction Internal Fixation Versus Replacement
- Conditions
- Acetabular Fracture
- Registration Number
- NCT03713853
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
Management of acetabular (hip) fractures in the geriatric population can be very challenging because of pre-existing medical comorbidities, pre-existing osteoporosis and increased risk of mortality.
The two most common treatment options for acetabular fractures are either surgical fixation using plates and screws to hold the fractured pieces in the correct position until the fracture has healed or surgical fixation in addition to a total hip replacement.
Surgical fixation requires prolonged immobilization of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Such patients, especially those who are frail and cognitively impaired, are unable to adhere to the immobilization restrictions, leading to an increased risk of fixation failure.
Patients who underwent open reduction internal fixation (ORIF) of an acetabular fracture were reported to have about 25 times greater incidence of hip replacement compared with general population matched controls.
Additionally, performing a subsequent hip replacement after a previous surgical fixation (ORIF) of an acetabular fracture, especially in the elderly population, can present a number of technical difficulties including; difficult dissection due to previous incision(s) and scarring, dealing with retained hardware, bony deficiency and the possibility of infected hardware.
The aim of the study is to perform a large cohort study to assess pain and physical function in patients 60 years and older who have sustained an acetabular fracture.
- Detailed Description
This is a multicentre observational cohort study, involving academic institutions affiliated with the Canadian Orthopaedic Trauma Society (COTS).
The study aims to compare two surgical treatments of acetabular fractures in patients 60 years of age and older. Patients who consent to participate will be included in the study and followed up as per standard of care up to 24 months after surgery. Participants will be treated for their acetabular fracture with either acute primary total hip arthroplasty (THA) together with open reduction internal fixation (ORIF) in the same surgery or ORIF alone as per surgeon discretion.
After surgery, patients will be assessed using patient-reported outcomes oxford hip score, which is a valid, reliable, responsive measure of pain and function during short-term and long-term follow-up for hip osteoarthritis and THA.
The European Quality of Life-5 Dimensions (EQ-5D), will be used to assess the patient's quality of life and health status. The questionnaire is short and easy to use and shows good responsiveness in orthopaedic patients who undergo a hip replacement.
Timed Up \& Go Test (TUG) measures functional mobility (in seconds), and is a well-validated predictor of mobility and falls in patients who undergo orthopaedic surgery and hip replacement.
All patients will be followed as per standard of care for their follow up visits at 6 weeks, 3, 6, 12 and 24 months.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 60 years of age or older
- Isolated and Displaced (more or equal to 2mm on any radiographic view) fracture of the acetabulum
- Patient requires surgical treatment, either THA+ORIF or ORIF surgeries
- Fracture is acute (within 3 weeks of injury)
- Patient was ambulatory (with or without walking aids) prior to their acetabular fracture injury
- Patient is able to provide informed consent to participation in the study
- Patient is able to read and understand English
- Presence of an active or chronic infection around the fracture (soft tissue or bone)
- Open/compound fracture
- Bilateral acetabular fractures
- Pathological fracture excluding osteoporosis
- Periprosthetic fracture (previous arthroplasty or hardware or ORIF in-situ). Hardware (screws or plates or nails or hemi-arthroplasty) on the femoral side are not excluded.
- Medical or surgical contraindication to surgery
- Dementia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oxford Hip score Questionnaire will be completed by patients at 3, 6 and 12-months follow-up and repeated measures analysis will be performed to assess the change across all time points (3,6 and 12-months) Oxford Hip Score is a short 12-item patient-reported outcome specifically designed and developed to assess function and pain during short-term and long-term follow-up for hip osteoarthritis and hip replacement surgery. It is valid, reliable, reproducible, and sensitive to clinically important changes. An increase in score indicate better joint function. A score between 40-48 indicates satisfactory joint function.
- Secondary Outcome Measures
Name Time Method Timed Up and Go (TUG) test Test will be completed at 3, 6,12 and 24-months follow-up TUG is a simple test used to assess a person's mobility (in seconds) and requires both static and dynamic balance. A line is placed on the floor 3 meters away from a chair where patient will be sitting.
When instructed to "GO" patient will stand, walk to a line on the floor at his/her regular pace, turn around and walk back to the chair and sit down.
The longer it takes for subject to complete the test, higher is the risk of fall and lower is the its functional mobility.
Reference values are:
60-69 years old = 8.1 seconds; 70-79 years old = 9.2 seconds; 80-99 years old = 11.3 seconds. Over 14 seconds is associate with high risk of fallVisual Analogue Scale of pain (VAS) Patients will indicate their pain level at 24, 48 hours, 6 weeks, 3, 6,12 and 24-months after surgery Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten)
Total Morphine Equivalents Usage The outcome will be assessed daily from the day of the surgery until the patient gets discharge from the hospital (24 hours up to 7 days) The sum (cumulative) of amount of opiates dosage (in milligram) prescribed daily (24hours) and converted in total morphine equivalent dosage (total dosage every 24 hours).
Health status and quality of life Questionnaire will be completed by patients at 6 weeks, 3, 6, 12 and 24-months follow-up The European Quality of Life-5 Dimensions (EQ-5D) is a patient-reported outcome where patients self-rate their level of severity of health status and health related quality of life. Consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.
Length of hospital stay The outcome will be assessed from the day of the surgery until the patient gets discharge from the hospital (at a maximum of 30 days after the surgery) How many days the patient stay in the hospital
Discharge location from the day of the surgery until the patient gets discharge from the hospital Site where the patient gets discharge, such as home, rehabilitation, acute care facility
Time to full-weight bearing Since the first day after surgery up to 12 months time (in days) that takes for the patient to start walking after the surgery
Time to return to work and activities of daily life from the day of the surgery up to 24 months follow up How many days until the patients return to their normal daily life activities such as independently walking, bathing/showering, grooming, dressing, etc. and How many days until patients return to work
Hospital Re-admission Within 30 days of discharge Any admission to any hospital after the patients is discharge from the hospital where he/she underwent the surgical treatment for acetabular fracture
Trial Locations
- Locations (1)
Unity Health Toronto - St Michael's Hospital
🇨🇦Toronto, Ontario, Canada