NCT01726855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
Last Updated

January 22, 2024

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

November 11, 2012

Last Update Submit

January 19, 2024

Conditions

Tendon Injuries

Keywords

tendon repair

Outcome Measures

Primary Outcomes (2)

  • the modified Strickland system

    3~12 months

  • degrees of the maximum active flexion at the distal interphalangeal joint

    3~12 months

Study Arms (2)

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

vascularized finger dorsal fascial flapPROCEDURE
dorsal fascial flap

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients requiring flexor tendon repair or reconstruction within zoneⅡ

You may qualify if:

  • patients requiring flexor tendon repair or reconstruction within zoneⅡ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2012

First Posted

November 15, 2012

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

July 1, 2012

Last Updated

January 22, 2024

Record last verified: 2012-11

Locations

CN(1)