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Acetabular FractureGATORNCT03713853

Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement

An observational study of Acetabular Fracture, run by Unity Health Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acetabular Fracture
How many people
104 participants
Where
1 siteCanada
Study dates
Dec 2026to Dec 2030
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Unity Health Toronto - St Michael's Hospital

    Toronto, Ontario, M5C 1R6

    Cassandra Tardif-Theriault, 4168646060 ext. 77117, Cassandra.tardif-theriault@unityhealth.to

    Ryan Khan, ryan.khan@unityhealth.to

    Recruiting

Other trials in Canada

About this study

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

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.

Read more

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.

Read the 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.

Keywords
Total hip replacement, Total hip arthroplasty, Open Reduction internal Fixation, Hip fixation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03713853
Study groupRoleWhat they receive
Total hip arthroplasty + ORIFPatients will receive acute primary total hip arthroplasty (THA) with open reduction internal fixation (ORIF) as a treatment for their acetabular fracture
Surgical Fixation (ORIF)Patients will receive open reduction internal fixation (ORIF) as a treatment for their acetabular fracture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (9)
  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

    Measured: Test will be completed at 3, 6,12 and 24-months follow-up

  2. 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)

    Measured: Patients will indicate their pain level at 24, 48 hours, 6 weeks, 3, 6,12 and 24-months after surgery

  3. 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).

    Measured: 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.

    Measured: Questionnaire will be completed by patients at 6 weeks, 3, 6, 12 and 24-months follow-up

  5. Length of hospital stay

    How many days the patient stay in the hospital

    Measured: 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)

  6. Discharge location

    Site where the patient gets discharge, such as home, rehabilitation, acute care facility

    Measured: from the day of the surgery until the patient gets discharge from the hospital

  7. Time to full-weight bearing

    time (in days) that takes for the patient to start walking after the surgery

    Measured: Since the first day after surgery up to 12 months

  8. Time to return to work and activities of daily life

    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

    Measured: from the day of the surgery up to 24 months follow up

  9. Hospital Re-admission

    Any admission to any hospital after the patients is discharge from the hospital where he/she underwent the surgical treatment for acetabular fracture

    Measured: Within 30 days of discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
104 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03713853
Sponsor's protocol ID
18-0303
Acronym
GATOR
Status last verified
Apr 2026
First submitted
16 Oct 2018
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23719343
  • 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.

    PubMed 29373451
  • Hamlin K, Lazaraviciute G, Koullouros M, Chouari T, Stevenson IM, Hamilton SW. Should Total Hip Arthroplasty be Performed Acutely in the Treatment of Acetabular Fractures in Elderly or Used as a Salvage Procedure Only? Indian J Orthop. 2017 Jul-Aug;51(4):421-433. doi: 10.4103/ortho.IJOrtho_138_16.

    PubMed 28790471
  • Ortega-Briones A, Smith S, Rickman M. Acetabular Fractures in the Elderly: Midterm Outcomes of Column Stabilisation and Primary Arthroplasty. Biomed Res Int. 2017;2017:4651518. doi: 10.1155/2017/4651518. Epub 2017 Jan 17.

    PubMed 28194414

Questions about this trial

What is this clinical trial studying?

An observational study of Acetabular Fracture, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cassandra Tardif-Theriault, BKin (4168646060 ext. 77117, cassandra.tardif-theriault@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03713853, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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