Is Force Control a Safe and Efficient Surgical Technology for Thoracolumbar Fusion Surgery? A Post Market Clinical...

Area of Science:

• Spinal Surgery
• Orthopedic Technology
• Biomechanical Engineering

Background:

• Posterior thoracolumbar fusion can lead to early screw loosening, a complication linked to high mechanical stress during rod connection.
• Force Control is an advanced surgical technology designed to minimize mechanical stress during spinal fixation.
• A novel pedicle screw system (PSS) incorporating lightweight instruments supports the Force Control principle.

Purpose of the Study:

• To evaluate the safety and efficacy of a novel PSS for Force Control fusion surgery.
• To assess the impact of Force Control on screw loosening rates and patient functional outcomes.
• To compare the performance of the novel PSS against a control group in literature.

Main Methods:

• A literature-controlled observational study involving 75 patients undergoing surgery with the novel PSS.
• Safety was assessed by comparing the 1-year screw loosening rate to a control group.
• Efficacy was evaluated by comparing the Oswestry Disability Index (ODI) improvement at 1 year to a control group.

Main Results:

• The 1-year screw loosening rate was 2.7%, demonstrating noninferiority to the control group's 9.2% (P = 0.005).
• Mean ODI improvement was 49.3, showing noninferiority to the control group's 35.2 (P < 0.001).
• Significant improvements were observed in 2-year ODI and visual analog scale back pain, with a 4.1% implant-related revision rate.

Conclusions:

• Force Control, utilizing a novel PSS with lightweight instruments, is a safe and effective method for posterior thoracolumbar fusion.
• This technique successfully identifies, controls, and reduces mechanical stress, leading to improved clinical outcomes.
• Patients undergoing Force Control fusion surgery benefit from reduced screw loosening and enhanced functional recovery.