Evaluation of the FrameLock reference-arc fixation device for image-guided surgery

Area of Science:

• Neurosurgery
• Medical Devices
• Surgical Navigation

Background:

• Image-guided surgery relies on accurate fixation devices for instrument placement.
• Traditional friction-fit frames may lack the stability required for complex procedures.
• Bone-anchored fixation offers a potentially more secure alternative.

Purpose of the Study:

• To compare the biomechanical stability of the bone anchored FrameLock (FL) and the friction fit FESS frame (FF).
• To evaluate the accuracy and displacement of both fixation devices in a clinical setting.

Main Methods:

• Cadaveric testing involved applying sequential impulse forces to FL and FF devices, measuring anatomic drift.
• A prospective clinical trial with 29 patients assessed the accuracy of each device before and after surgery.
• Statistical analysis, including linear regression, was used to correlate drift with impulse force and procedure duration.

Main Results:

• The FL exhibited significantly less anatomic drift than the FF across most tested impulse forces (P < 0.01).
• Average clinical displacement was substantially lower for the FL (0.07 mm) compared to the FF (1.02 mm) (P < 0.0009).
• Linear regression showed minimal correlation between drift and procedure duration for FL (y = 0.02x), unlike FF (y = 0.61x).

Conclusions:

• The bone anchored FL provides significantly greater stability than the friction fit FF.
• FL demonstrates superior resistance to displacement, making it a more reliable option for image-guided surgery.
• The enhanced stability of FL may lead to improved accuracy and reduced complications in surgical navigation.