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Multicenter Randomized Controlled Clinical Trial to Compare the Safety and Performance of Two Bone Flap Fixation
Álvaro Gómez de la Riva1,2, Marta Rico3, Matjaz Voršič4
1Neurosurgery Department, Hospital Univesitario La Paz, Madrid , Spain.
Operative Neurosurgery (Hagerstown, Md.)
|November 25, 2024
Summary
Clamp-like devices (Cranial LOOP) offer comparable craniotomy closure to traditional plates and screws (P&S). Cranial LOOP shows potential advantages in affordability and patient comfort, with no adverse events reported.
Area of Science:
- Neurosurgery
- Biomaterials
- Medical Devices
Background:
- Craniotomy closure traditionally uses plates and screws (P&S).
- Polymeric clamp-like devices offer potential advantages over P&S.
- Clinical evidence comparing these methods is limited.
Purpose of the Study:
- To compare the clinical safety and performance of clamp-like devices (Cranial LOOP) versus P&S for craniotomy closure.
- To evaluate bone flap alignment, adverse events, usability, and patient-reported inconveniences.
Main Methods:
- Prospective, double-arm, multicenter randomized controlled trial.
- 60 patients undergoing craniotomy were randomized into two groups: P&S or Cranial LOOP.
- Bone flap alignment assessed via neuroimaging at 6 months; secondary outcomes included adverse events and usability.
Main Results:
- Median of 3 Cranial LOOP devices or 4 plates and 8 screws used per patient.
- Both groups achieved equally good bone flap alignment.
- Surgeons reported high satisfaction and ease of use for both systems; no adverse events reported. Cranial LOOP had no associated patient discomfort, unlike P&S.
Conclusions:
- Cranial LOOP demonstrates equivalent performance to P&S for cranial bone flap fixation.
- Cranial LOOP may offer advantages in cost-effectiveness due to fewer devices used.
- Cranial LOOP provides superior patient comfort compared to P&S.
