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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02625038

Acronym

CARDFOREARM

Enrollment

110

Registered

2015-12-09

Start date

2014-09-30

Completion date

2019-01-31

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic or Congenital Bone Deformity

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.

Interventions

DEVICEEUDAMED CIV-14-03-011940

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
3D difference between preoperative plan and surgery	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

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026