CT-based Evaluation of the Intraoperative Implementation Accuracy of 3D-planned Osteotomies of the Hand and Forearm Performed With Patient-specific Instruments
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Posttraumatic or Congenital Bone Deformity
- Sponsor
- Balgrist University Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- 3D difference between preoperative plan and surgery
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
3D difference between preoperative plan and surgery
Time Frame: 42 month
For each reduced fragment the 3D difference in all 6 degrees of freedom (3xrotation, 3xtranslation) is quantified by comparing pre- and postoperative CT.
Secondary Outcomes
- Surgical Outcome(42 month)