Are large fracture trials really possible? What we have learned from the randomized controlled damage control study?

Area of Science:

• Orthopedic surgery
• Trauma care
• Evidence-based medicine

Background:

• Randomized controlled trials (RCTs) are the gold standard in evidence-based medicine but are rarely conducted in orthopedic surgery.
• A trend towards 'damage control orthopedics' (DCO) in multiple trauma patients lacks robust evidence of superiority.
• This study addresses the practical challenges of implementing RCTs in this field.

Purpose of the Study:

• To present unexpected difficulties encountered during a randomized controlled trial on DCO for femur shaft fractures in multiple trauma patients.
• To discuss the discrepancies between theoretical trial planning and practical implementation.
• To evaluate published strategies for conducting large fracture trials.

Main Methods:

• A multicenter randomized controlled trial (RCT) was designed to assess the efficacy of risk-adapted DCO for femur shaft fractures in multiple trauma patients.
• The study compared planning and execution methods against established trial conduct guidelines.
• Level I evidence was targeted.

Main Results:

• The study was methodically planned, meeting prerequisites for a large fracture trial.
• Unexpected difficulties, primarily multifactorial low patient recruitment, led to the suspension of funding after 2.5 years.
• The trial, despite its design, failed to complete due to insufficient participant enrollment.

Conclusions:

• Performing large fracture trials is significantly more challenging in practice than in theory.
• Even theoretically sound trial designs can fail during implementation.
• The feasibility of conducting large-scale fracture trials remains a critical question for the field.