Completed

NCT Number: NCT02625038

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

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.

Completed

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Key information

Conditions

Posttraumatic or Congenital Bone Deformity

Age range

15 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Balgrist

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUDAMED CIV-14-03-011940

Device

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

Time frame: 42 month

The surgical outcome is assessed by comparing DASH- and PRWE-scores pre- and postoperatively.

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

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

Acronym: CARDFOREARM

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Dec 9, 2015
Registry last updated: Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.