Endoscopic Transfer of Flexor Hallucis Longus Tendon for... | NCT02996253

Studies
Endoscopic Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture

NCT02996253

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Mar 22, 2023Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Achilles Tendon Rupture

Interventions

FHL transfer

Countries

Norway

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Feb 2022Actual

Completion Date

Feb 2024Estimated

First Submitted Date

Dec 7, 2016

First Submission Date that Met QC Criteria

Dec 14, 2016

First Posted Date

Dec 19, 2016Estimated

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 21, 2023

Last Update Posted Date

Mar 22, 2023Actual

Name	Class
Central Hospital, Fredrikstad	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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 transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL transfer may reduce the risk for soft tissue problems. Functional outcome parameters are investigated, wound/soft tissue complications registered.

Detailed Description

The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot scores at 80-89. The extensive surgical field by either a two-incision approach or a single longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may reduce the risk for soft tissue problems while retaining a good functional outcome. Several functional outcome measures and scores are evaluated a year after surgery.

Prospective study for evaluation of the surgical procedure.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

38Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FHL transfer	Procedure	endoscopic transfer og flexor hallucis longus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score		one year after FHL transfer

Secondary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale for Pain (VAS pain) score	patient reported outcome	3, 6 and 12 months after FHL transfer
patient reported function score (PRFS)	patient reported Activity related disability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic Achilles Tendon Rupture

Exclusion Criteria:

Pregnancy
BMI<18.5 or >39.9
Insufficient Norwegian Language proficiency lack of communication skills local skin conditions at site for planned surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients With chronic Achilles Tendon Rupture

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elisabeth E Husebye, MD, PhD	Oslo University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0450	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided