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

Unity Health Toronto

Status: Enrolling

Conditions: Acetabular Fracture

Study type: Observational

Funder types: Other

Identifiers

NCT03713853

18-0303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

104 participants in 2 patient groups

Total hip arthroplasty + ORIF

Description:

Patients will receive acute primary total hip arthroplasty (THA) with open reduction internal fixation (ORIF) as a treatment for their acetabular fracture

Surgical Fixation (ORIF)

Description:

Patients will receive open reduction internal fixation (ORIF) as a treatment for their acetabular fracture