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Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement (GATOR)

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ClinicalTrials.gov Identifier: NCT03713853
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, 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 Canadian randomized controlled trial to compare pain and physical function in patients 60 years and older who have sustained an acetabular fracture.


Condition or disease Intervention/treatment Phase
Acetabular Fracture Procedure: Total hip arthroplasty + ORIF Procedure: Surgical Fixation (ORIF) Not Applicable

Detailed Description:

This is randomized, controlled, multicentre superiority trial with two parallel groups, 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 randomized through a web-based, central randomization system to one of the two treatment arms. One treatment arm will consist of patients who are treated with acute primary total hip arthroplasty (THA) together with open reduction internal fixation (ORIF) in the same surgery and the other treatment group will undergo ORIF alone.

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 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, 12 and 24 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomized two treatment groups:

  1. Acute primary total hip arthroplasty (THA) + ORIF or
  2. Open reduction internal fixation (ORIF) alone
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GATOR: Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Total Hip Arthroplasty for Geriatric Acetabular Fractures
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Total hip arthroplasty + ORIF
Patients will receive acute primary total hip arthroplasty (THA) with open reduction internal fixation (ORIF) as a treatment for their acetabular fracture
Procedure: Total hip arthroplasty + ORIF
A trained orthopaedic surgeon uses specific reduction technique, plates, and screws, to restore structural integrity and alignment of an acetabular fracture (ORIF), and performs a hip replacement (THA), where the hip joint is replaced by an artificial hip (prosthetic implant).

Active Comparator: Surgical Fixation (ORIF)
Patients will receive open reduction internal fixation (ORIF) as a treatment for their acetabular fracture
Procedure: Surgical Fixation (ORIF)
A trained orthopaedic surgeon uses specific reduction technique, plates and screws, to restore structural integrity and alignment of an acetabular fracture (ORIF)




Primary Outcome Measures :
  1. Oxford Hip score [ Time Frame: Questionnaire will be completed by patients at 6 weeks, 3, 12 and 24-months follow-up and repeated measures analysis will be performed to assess the change across all time points (6 weeks, 3, 12 and 24-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 :
  1. Timed Up and Go (TUG) test [ Time Frame: Test will be completed at 6 weeks, 3, 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 fall


  2. Visual Analogue Scale of pain (VAS) [ Time Frame: Patients will indicate their pain level at 24, 48 hours, 6 weeks, 3, 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)

  3. 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) ]
    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).

  4. Health status and quality of life [ Time Frame: Questionnaire will be completed by patients at 6 weeks, 3, 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.

  5. 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) ]
    How many days the patient stay in the hospital

  6. Discharge location [ Time Frame: 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

  7. Time to full-weight bearing [ Time Frame: Since the first day after surgery up to 12 months ]
    time (in days) that takes for the patient to start walking after the surgery

  8. Time to return to work and activities of daily life [ Time Frame: 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

  9. Hospital Re-admission [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Any fracture pattern whereby the most responsible physician (MRP) feels there may be equipoise between the two treatment modalities (ORIF vs THA)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713853


Contacts
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Contact: Luana Melo, PhD 4168646060 melol@smh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Amir Khoshbin, MD St. Michael's Hospital, Toronto

Publications:

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03713853     History of Changes
Other Study ID Numbers: 18-0303
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Michael's Hospital, Toronto:
Total hip replacement
Total hip arthroplasty
Open Reduction internal Fixation
Hip fixation

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries