Prevention of Adhesions Following Flexor Tendon Injury Wi... | NCT01726855

Studies
Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap

NCT01726855

Sponsor

The Second Hospital of Tangshan

Status

Completed

Last Update Posted

Jan 22, 2024Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Tendon Injuries

Interventions

vascularized finger dorsal fascial flap

Countries

China

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

Nov 2012

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

Jan 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 11, 2012

First Submission Date that Met QC Criteria

Nov 14, 2012

First Posted Date

Nov 15, 2012Estimated

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

Jan 19, 2024

Last Update Posted Date

Jan 22, 2024Actual

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

The purpose of this study was to report a new method of flexor tendon repair in zone II with combined standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger volar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair in zone II with this new technique were compared with those of 32 patients (Group B) with flexor tendon repair in zone II with standard modified Kessler technique. This new technique may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.

Detailed Description

Not provided

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dorsal fascial flap		combined with standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger palmar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons.	Procedure: vascularized finger dorsal fascial flap
standard modified Kessler technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vascularized finger dorsal fascial flap	Procedure		dorsal fascial flap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the modified Strickland system		3~12 months
degrees of the maximum active flexion at the distal interphalangeal joint		3~12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients requiring flexor tendon repair or reconstruction within zoneⅡ

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients requiring flexor tendon repair or reconstruction within zoneⅡ

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Second Hospital of Tangshan		Tangshan	Hebei	063000	China