Patient-specific instruments: industry's innovation with a surgeon's interest

Area of Science:

• Orthopaedic Surgery
• Medical Device Technology
• Surgical Innovation

Background:

• Patient-specific instruments (PSI) are increasingly utilized in orthopaedic procedures.
• The adoption and perception of PSI in knee arthroplasty require investigation.
• Understanding the market volume and surgeon acceptance is crucial for future development.

Purpose of the Study:

• To quantify the volume of patient-specific instruments (PSI) used in knee arthroplasty across Europe and globally.
• To assess knee arthroplasty surgeons' acceptance and expectations regarding PSI.
• To explore medico-legal aspects associated with the use of PSI.

Main Methods:

• Surveys distributed to seven orthopaedic implant manufacturers for sales data (2011-2012).
• Direct voting system survey at the Belgian Knee Society Open Meeting for surgeon opinions.
• Consultation with a medico-legal expert on PSI-related issues.

Main Results:

• Global PSI volume reached 82,556 total knee arthroplasties (TKA) in 2012, with Europe accounting for 17,515 TKAs.
• Biomet led the market with their Signature system, holding 27% global market share.
• 80% of Belgian surgeons showed interest in PSI, particularly for improving surgical accuracy and in unicompartmental arthroplasty; 47% attributed company responsibility for issues.

Conclusions:

• Patient-specific instruments (PSI) hold significant potential in knee arthroplasty if they demonstrably enhance surgical accuracy.
• Increased surgical efficiency is a key factor for surgeon adoption of PSI.
• Addressing medico-legal responsibilities and ensuring surgeon validation of planning are critical for PSI implementation.