ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a...

Area of Science:

• Gerontology
• Orthopedic Surgery
• Clinical Trials

Background:

• Pelvic fragility fractures (PFF) are common in older adults, leading to significant morbidity and mortality.
• Current non-surgical management presents challenges in pain control and early mobilization.
• Minimally invasive surgical stabilization shows promise for improving PFF outcomes.

Purpose of the Study:

• To assess the feasibility and inform the design of a future randomized controlled trial comparing surgical and non-surgical management of acute sacral fragility fractures.
• To evaluate recruitment, adherence, and safety of a potential surgical intervention for PFF.
• To gather preliminary data on clinical and economic outcomes for future trial planning.

Main Methods:

• The ASSERT trial is a single-site, randomized controlled feasibility study comparing surgical stabilization to non-surgical management for acute sacral fragility fractures in individuals aged 70 and over.
• Participants are randomized 1:1 to surgical or non-surgical groups, with follow-up at 2, 4, and 12 weeks, and safety data at 52 weeks.
• Qualitative interviews with participants and clinicians supplement quantitative data collection on pain, mobility, analgesia, resource use, and quality of life.

Main Results:

• Recruitment is ongoing, with pre-results available.
• The study is designed to determine the feasibility of recruitment, adherence to randomization, and safety of interventions.
• Descriptive data analysis will inform future sample size calculations and outcome measures.

Conclusions:

• This feasibility study is crucial for designing a definitive randomized controlled trial on surgical management of pelvic fragility fractures.
• Findings will guide the optimal methodology for future research into PFF treatment.
• The study contributes to understanding the potential benefits of surgical stabilization for improving patient outcomes in this population.