NCT02625038

Evaluation of the Intraoperative Accuracy of 3D-planned and Guided Osteotomies of the Hand and Forearm

CT-based Evaluation of the Intraoperative Implementation Accuracy of 3D-planned Osteotomies of the Hand and Forearm Performed With Patient-specific Instruments

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Balgrist University Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies that are performed with patient-specific instruments. Due to the higher accuracy achieved it is expected that complaints can be resolved or effectively revealed. The Research hypothesis to prove is "The medical product permits the surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus, carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and 2º. Secondary outcome is an assessment of the surgical outcome using the "Disabilities of the Arm, Shoulder and Hand" (DASH) and the "Patient related wrist Evaluation" (PRWE) scores.

Conditions

• Posttraumatic or Congenital Bone Deformity

Interventions

Type	Name	Description
DEVICE	EUDAMED CIV-14-03-011940

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2015-12-09
• Last updated: 2019-03-28

Locations

1 site across 1 country: Switzerland