Percutaneous Tenotomy of the Toe Flexor Tendon is a Simpl... | NCT01725893

Studies
Percutaneous Tenotomy of the Toe Flexor Tendon is a Simple and Efficient Method in Treating Checkrein Deformity

NCT01725893

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 14, 2012Estimated

Enrollment

14Estimated

Phase

Not provided

Conditions

Claw Toe

Interventions

Not provided

Countries

Taiwan

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jan 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Sep 25, 2012

First Submission Date that Met QC Criteria

Nov 13, 2012

First Posted Date

Nov 14, 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

Nov 13, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Hospital, National Taiwan University Hospital (NTUH) Research Ethics Committee (REC), National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

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

Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the treatment of choice and many methods have been proposed. The purpose of this study is to evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor tendons.

Detailed Description

The investigators reviewed fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010. Five patients received FHL and flexor digitorum longus (FDL) tenolysis at the musculotendinous junction; among them, two also underwent Z-plasty lengthening of the FHL tendon. Nine patients underwent percutaneous segmental toe flexor tenotomy. The Hallux Metatarsophalangeal- Interphalangeal Scale (Hallux MTP-IP scale) and Foot and Ankle Outcome Score (FAOS), English version LK1.0 self-explanatory questionnaire were used to evaluate the functional outcomes.

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

14Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010.

Exclusion Criteria:

Patients who had static or rigid claw toe deformity
Patients who had claw toe deformity secondary to neuromuscular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

73 Years

Standard Ages

AdultOlder Adult

Study Population

There were fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin-Tzer Ho, M.D	Contact	886 2 23123456	62515	herginger@gmail.com

Overall Officials

Name	Affiliation	Role
Hong-Nerng Ho, Professor	National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei	Taiwan	100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18669962	Result	Lee HS, Kim JS, Park SS, Lee DH, Park JM, Wapner KL. Treatment of checkrein deformity of the hallux. J Bone Joint Surg Br. 2008 Aug;90(8):1055-8. doi: 10.1302/0301-620X.90B8.20563.

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases