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

Balgrist University Hospital

Status

Completed

Conditions

Posttraumatic or Congenital Bone Deformity

Treatments

Device: EUDAMED CIV-14-03-011940

Study type

Interventional

Funder types

Other

Identifiers

NCT02625038

2014-MD-0016

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

15 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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