FLEX-Trial: Prospective Sonographic Assessment Of Healing... | NCT01013428 | Trialant

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FLEX-Trial: Prospective Sonographic Assessment Of Healing... | NCT01013428 | Trialant

Studies
FLEX-Trial: Prospective Sonographic Assessment Of Healing Process Following Suture of Profound Flexor Tendon Due to Traumatic Rupture of FDP-Tendon in Zone II.

NCT01013428

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Mar 30, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Tendon Injury

Interventions

Ultrasound

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

NCT01013428

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

001

Secondary IDs

Not provided

Brief Title

FLEX-Trial: Prospective Sonographic Assessment Of Healing Process Following Suture of Profound Flexor Tendon Due to Traumatic Rupture of FDP-Tendon in Zone II.

Official Title

Not provided

Acronym

Not provided

Organization

University of ZurichOTHER

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Nov 2009

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Nov 11, 2009

First Submission Date that Met QC Criteria

Nov 12, 2009

First Posted Date

Nov 13, 2009Estimated

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 29, 2016

Last Update Posted Date

Mar 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gustav Andreisek, md, University of ZurichPrincipal Investigator

Lead Sponsor

University of ZurichOTHER

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

To prospectively assess the healing process following suture of profound fexor tendon due to traumatic rupture of FDP-Tendon in Zone II by ultrasound.

Detailed Description

Not provided

Conditions Module

Conditions

Tendon Injury

Keywords

Traumatic Rupture of Tendon

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Other	Ultrasound will be used to evaluate tendons.

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

All patients with traumatic rupture of FDP-tendon in zone II.

Exclusion criteria:

< 18years;
Fracture;
crush injury; (partial) amputation;
RA;
CPPD;
CP;

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Zurich			Switzerland

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Cohort

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

ID	Term
D013708	Tendon Injuries

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided