Evaluation of the Intraoperative Accuracy of 3D-planned a... | NCT02625038

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

NCT02625038

Sponsor

Balgrist University Hospital

Status

Completed

Last Update Posted

Mar 28, 2019Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Posttraumatic or Congenital Bone Deformity

Interventions

EUDAMED CIV-14-03-011940

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jan 2019Actual

Completion Date

Jan 2019Actual

First Submitted Date

Nov 27, 2015

First Submission Date that Met QC Criteria

Dec 6, 2015

First Posted Date

Dec 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional	Experimental	3D-planned osteotomies with patient-specific guides	Device: EUDAMED CIV-14-03-011940

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUDAMED CIV-14-03-011940	Device		Interventional

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Schweizer, Prof.	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Balgrist		Zurich		8008	Switzerland