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

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

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.

For each reduced fragment the 3D difference in all 6 degrees of freedom (3xrotation, 3xtranslation) is quantified by comparing pre- and postoperative CT.

Inclusion criteria Posttraumatic or congenital bone deformity or pseudoarthrosis in the field of hand Surgery requiring correction by corrective osteotomy Clinical indication for a computer tomography scan of the forearms > 18 years old written informed consent Exclusion criteria pregnant or nursing women other clinical significant accompanying symptoms (Tumor, infection) non-compliance of the patient to follow the clinical study protocol, drug or alcohol abuse Participation in a different clinical trial within the last 30 days before inclusion or during the study