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

March 21, 2023 updated by: Elisabeth Ellingsen Husebye, Oslo University Hospital

Endoscopic Assisted Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture. A Prospective Multi Center Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Are H Stoedle, MD
  • Phone Number: 0047 97174507
  • Email: arhauk@us-hf.no

Study Locations

  • Norway
      • Oslo, Norway, 0450
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients With chronic Achilles Tendon Rupture

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale for Pain (VAS pain) score
Time Frame: 3, 6 and 12 months after FHL transfer
patient reported outcome
3, 6 and 12 months after FHL transfer
patient reported function score (PRFS)
Time Frame: 6, 12 months
patient reported Activity related disability
6, 12 months
Magnetic resonance imagine (MRI)
Time Frame: one year post surgery
FHL hypertrophy
one year post surgery
functional test battery
Time Frame: 12 months
jump- and strength tests
12 months
local wound conditions
Time Frame: within 12 weeks
wound infection
within 12 weeks
AOFAS hindfoot
Time Frame: 3,6,12 months
3,6,12 months
VISA-A
Time Frame: 6 months after surgery
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Central Hospital, Fredrikstad

Investigators

  • Study Chair: Elisabeth E Husebye, MD, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 1, 2022

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/16389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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