Reuse of external fixation components: a randomized trial

Area of Science:

• Orthopedic surgery
• Biomedical engineering
• Health economics

Background:

• External fixation devices are crucial in trauma care but are costly single-use items in the US.
• Approved refurbishment processes exist for non-implantable components, presenting a potential cost-saving alternative.

Purpose of the Study:

• To evaluate the safety, efficacy, and fiscal impact of a refurbishment program for external fixation devices.
• To compare outcomes of new versus refurbished external fixation components in patients with fractures.

Main Methods:

• A randomized clinical trial was conducted at a Level I trauma center.
• 96 eligible patients with fractures were randomized to receive either new or refurbished external fixation components (all pins were new).
• Outcomes measured included pin tract infections, loss of fixation, and component loosening.

Main Results:

• No statistically significant differences were observed in pin tract infections (46% vs. 52%), loss of fixation (4% vs. 4%), or component loosening (1% vs. 1%) between new and refurbished frames.
• The study treated 96 fractures, including distal radius, pilon, and tibial plateau fractures.

Conclusions:

• Refurbishment programs for external fixation devices are safe and effective, with no compromise in clinical outcomes.
• This specific program demonstrated an actual cost saving of $65,452, with a potential to save 25% of the cost of all new frames.
• Patient acceptance remains a challenge, as 65% of eligible patients declined participation due to refurbished clamps.