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

NCT02625038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-03-28

No results posted yet for this study

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

Interventions

DEVICE

EUDAMED CIV-14-03-011940

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Andreas Schweizer, Prof. · University of Zurich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02625038 on ClinicalTrials.gov