Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement — GATOR  

Acetabular Fracture Clinical Trial

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

Status Not yet recruiting

Clinical 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.

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone

• NCT number: NCT03713853
• Study type: Observational [Patient Registry]
• Source: Unity Health Toronto
• Contact: Luana Melo, PhD
• Phone: 4168646060
• Email: luana.melo@unityhealth.to
• Status: Not yet recruiting
• Start date: March 2024
• Completion date: April 2030