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

Posttraumatic or Congenital Bone Deformity Clinical Trial

— CARDFOREARM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625038
• Other study ID #: 2014-MD-0016
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: January 2019

Study information

• Verified date: March 2019
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic or Congenital Bone Deformity

Intervention

Device:
• EUDAMED CIV-14-03-011940

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical Outcome	The surgical outcome is assessed by comparing DASH- and PRWE-scores pre- and postoperatively.	42 month