Clinical trial NCT03713853: Geriatric Acetabular FracTures: Open Reduction Internal Fixation Versus Replacement
Official title: GATOR: Geriatric Acetabular FracTures: Open Reduction Internal Fixation Versus Replacement - a Large Cohort of Acute Open Reduction Internal Fixation (ORIF) Versus Total Hip Arthroplasty for Geriatric Acetabular Fractures
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acetabular Fracture
Keywords: Total hip replacement
Total hip arthroplasty
Open Reduction internal Fixation
Hip fixation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oxford Hip score
timeFrame: 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:
measure: Timed Up and Go (TUG) test
timeFrame: Test will be completed at 3, 6,12 and 24-months follow-up
measure: Visual Analogue Scale of pain (VAS)
timeFrame: Patients will indicate their pain level at 24, 48 hours, 6 weeks, 3, 6,12 and 24-months after surgery
measure: Total Morphine Equivalents Usage
timeFrame: 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)
measure: Health status and quality of life
timeFrame: Questionnaire will be completed by patients at 6 weeks, 3, 6, 12 and 24-months follow-up
measure: Length of hospital stay
timeFrame: 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)
measure: Discharge location
timeFrame: from the day of the surgery until the patient gets discharge from the hospital
measure: Time to full-weight bearing
timeFrame: Since the first day after surgery up to 12 months
measure: Time to return to work and activities of daily life
timeFrame: from the day of the surgery up to 24 months follow up
measure: Hospital Re-admission
timeFrame: Within 30 days of discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto - St Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Amir Khoshbin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: O'Toole RV, Hui E, Chandra A, Nascone JW. How often does open reduction and internal fixation of geriatric acetabular fractures lead to hip arthroplasty? J Orthop Trauma. 2014 Mar;28(3):148-53. doi: 10.1097/BOT.0b013e31829c739a.
citation: Weaver MJ, Smith RM, Lhowe DW, Vrahas MS. Does Total Hip Arthroplasty Reduce the Risk of Secondary Surgery Following the Treatment of Displaced Acetabular Fractures in the Elderly Compared to Open Reduction Internal Fixation? A Pilot Study. J Orthop Trauma. 2018 Feb;32 Suppl 1:S40-S45. doi: 10.1097/BOT.0000000000001088.
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