Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement
ConditionAcetabular Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Presence of an active or chronic infection around the fracture (soft tissue or bone)
Open/compound fracture
Bilateral acetabular fractures
Pathological fracture excluding osteoporosis
Trial population
All patients 60 years of age and older, presenting at the participant hospital sites with a displaced acetabular fracture and who need surgery to fix their fracture, either total hip replacement (THA) together with surgical fixation (ORIF) or surgical fixation (ORIF) alone, will be screened for the study. Patients who meet the trial eligibility criteria will be approached by a member of the research team. The study will be explained in detail and written informed consent will be undertaken with those patients who wish to participate in the study. Outcomes for participants will be measured and captured during regularly scheduled clinic/hospital visits
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
104 Participants
are grouped into 2 trial groupsGroup A: Total hip arthroplasty + ORIF
Group B: Surgical Fixation (ORIF)
Trial outcomes
Primary outcomes
1
Oxford Hip score
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.
Time frame
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)Secondary outcomes
1
Timed Up and Go (TUG) test
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 fall
Time frame
Test will be completed at 3, 6,12 and 24-months follow-up2
Visual Analogue Scale of pain (VAS)
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)
Time frame
Patients will indicate their pain level at 24, 48 hours, 6 weeks, 3, 6,12 and 24-months after surgery3
Total Morphine Equivalents Usage
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).
Time frame
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)4
Health status and quality of life
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.
Time frame
Questionnaire will be completed by patients at 6 weeks, 3, 6, 12 and 24-months follow-upSponsors and contacts
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Source ClinicalTrials.gov