Acetabular Fractures in older patients Intervention Trial (AceFIT): a feasibility triple-arm randomized controlled...

Area of Science:

• Orthopedic Surgery
• Geriatric Medicine
• Clinical Trial Design

Background:

• Acetabular fractures are common in older adults, posing challenges for treatment and recovery.
• Existing treatment options include surgical fixation, combined surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical management.
• Evidence is needed to determine the optimal treatment strategy for this patient population.

Purpose of the Study:

• To assess the feasibility of conducting a randomized controlled trial (RCT) for acetabular fractures in patients over 60 years old.
• To compare the feasibility and outcomes of surgical fixation, fix-and-replace, and non-surgical treatments.
• To inform the design of a larger, multinational RCT.

Main Methods:

• A three-arm pilot randomized controlled trial (RCT) was conducted across seven UK NHS centers.
• Patients aged over 60 with displaced acetabular fractures were recruited.
• Feasibility outcomes included patient willingness to participate, recruitment capability, and dropout rates. Primary clinical outcome was the EuroQol five-dimension questionnaire (EQ-5D) at six months.

Main Results:

• Sixty patients were recruited between December 2017 and December 2019, with a median age of 77.4 years.
• A 98% response rate was achieved for the primary EQ-5D outcome at six months.
• Withdrawal, death, and loss to follow-up rates were low, indicating good feasibility.

Conclusions:

• This pilot study demonstrates the feasibility of a full-scale RCT for acetabular fractures in older patients.
• International recruitment is necessary for a future multinational RCT, with estimated sample sizes of 1,474 or 1,974 patients.
• Optimal patient recovery requires multidisciplinary input from surgeons, anaesthetists, and ortho-geriatricians.