Evaluation of the Intraoperative Accuracy of 3D-planned and Guided Osteotomies of the Hand and Forearm
- Conditions
- Posttraumatic or Congenital Bone Deformity
- Interventions
- Device: EUDAMED CIV-14-03-011940
- Registration Number
- NCT02625038
- Lead Sponsor
- Balgrist University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional EUDAMED CIV-14-03-011940 3D-planned osteotomies with patient-specific guides
- Primary Outcome Measures
Name Time Method 3D difference between preoperative plan and surgery 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 Outcome Measures
Name Time Method Surgical Outcome 42 month The surgical outcome is assessed by comparing DASH- and PRWE-scores pre- and postoperatively.
Trial Locations
- Locations (1)
University Hospital Balgrist
🇨🇭Zurich, Switzerland