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

NCT ID: NCT02625038

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-01-31

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.

Conditions

Posttraumatic or Congenital Bone Deformity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

3D-planned osteotomies with patient-specific guides

Group Type: EXPERIMENTAL

EUDAMED CIV-14-03-011940

Intervention Type: DEVICE

Interventions

EUDAMED CIV-14-03-011940

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Balgrist University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Schweizer, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2014-MD-0016

Identifier Type: -

Identifier Source: org_study_id