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

Overview

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.

Primary outcome measures

• Oxford Hip score [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 outcome measures (9)

• Timed Up and Go (TUG) test [Time frame: Test will be completed at 3, 6,12 and 24-months follow-up]
• Visual Analogue Scale of pain (VAS) [Time frame: Patients will indicate their pain level at 24, 48 hours, 6 weeks, 3, 6,12 and 24-months after surgery]
• Total Morphine Equivalents Usage [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)]
• Health status and quality of life [Time frame: Questionnaire will be completed by patients at 6 weeks, 3, 6, 12 and 24-months follow-up]
• Length of hospital stay [Time frame: 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)]
• Discharge location [Time frame: from the day of the surgery until the patient gets discharge from the hospital]
• Time to full-weight bearing [Time frame: Since the first day after surgery up to 12 months]
• Time to return to work and activities of daily life [Time frame: from the day of the surgery up to 24 months follow up]
• Hospital Re-admission [Time frame: Within 30 days of discharge]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Canada · 1 center

• Unity Health Toronto - St Michael's Hospital — Toronto

Publications

• Cahueque M, Martinez M, Cobar A, Bregni M. Early reduction of acetabular fractures decreases the risk of post-traumatic hip osteoarthritis? J Clin Orthop Trauma. 2017 Oct-Dec;8(4):320-326. doi: 10.1016/j.jcot.2017.01.001. Epub 2017 Jan 13. PMID 29062212
• Firoozabadi R, Cross WW, Krieg JC, Routt MLC. Acetabular Fractures in the Senior Population- Epidemiology, Mortality and Treatments. Arch Bone Jt Surg. 2017 Mar;5(2):96-102. PMID 28497099
• Boelch SP, Jordan MC, Meffert RH, Jansen H. Comparison of open reduction and internal fixation and primary total hip replacement for osteoporotic acetabular fractures: a retrospective clinical study. Int Orthop. 2017 Sep;41(9):1831-1837. doi: 10.1007/s00264-016-3260-x. Epub 2016 Aug 10. PMID 27511470
• Hanschen M, Pesch S, Huber-Wagner S, Biberthaler P. Management of acetabular fractures in the geriatric patient. SICOT J. 2017;3:37. doi: 10.1051/sicotj/2017026. Epub 2017 May 25. PMID 28534471
• Morison Z, Moojen DJ, Nauth A, Hall J, McKee MD, Waddell JP, Schemitsch EH. Total Hip Arthroplasty After Acetabular Fracture Is Associated With Lower Survivorship and More Complications. Clin Orthop Relat Res. 2016 Feb;474(2):392-8. doi: 10.1007/s11999-015-4509-1. PMID 26335343
• Khurana S, Nobel TB, Merkow JS, Walsh M, Egol KA. Total Hip Arthroplasty for Posttraumatic Osteoarthritis of the Hip Fares Worse Than THA for Primary Osteoarthritis. Am J Orthop (Belle Mead NJ). 2015 Jul;44(7):321-5. PMID 26161760
• Henry PDG, Si-Hyeong Park S, Paterson JM, Kreder HJ, Jenkinson R, Wasserstein D. Risk of Hip Arthroplasty After Open Reduction Internal Fixation of a Fracture of the Acetabulum: A Matched Cohort Study. J Orthop Trauma. 2018 Mar;32(3):134-140. doi: 10.1097/BOT.0000000000001048. PMID 29462122
• 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. PMID 23719343

Identifiers

NCT: NCT03713853 · 18-0303

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗