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Clinical Trials/NCT02625038
NCT02625038
Completed
Not Applicable

CT-based Evaluation of the Intraoperative Implementation Accuracy of 3D-planned Osteotomies of the Hand and Forearm Performed With Patient-specific Instruments

Balgrist University Hospital1 site in 1 country110 target enrollmentSeptember 2014

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
January 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Balgrist University Hospital
Responsible Party
Sponsor

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)

Study Sites (1)

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