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

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic or Congenital Bone Deformity
• Intervention / Treatment: Device: EUDAMED CIV-14-03-011940

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • University Hospital Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; 3D-planned osteotomies with patient-specific guides	Device: EUDAMED CIV-14-03-011940

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D difference between preoperative plan and surgery	For each reduced fragment the 3D difference in all 6 degrees of freedom (3xrotation, 3xtranslation) is quantified by comparing pre- and postoperative CT.	42 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Outcome	The surgical outcome is assessed by comparing DASH- and PRWE-scores pre- and postoperatively.	42 month

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Andreas Schweizer, Prof., University of Zurich

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: November 27, 2015
• First Submitted That Met QC Criteria: December 6, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2014-MD-0016