NCT02996253

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

6.2 years

First QC Date

December 7, 2016

Last Update Submit

March 21, 2023

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (1)

  • The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score

    one year after FHL transfer

Secondary Outcomes (7)

  • Visual Analogue Scale for Pain (VAS pain) score

    3, 6 and 12 months after FHL transfer

  • patient reported function score (PRFS)

    6, 12 months

  • Magnetic resonance imagine (MRI)

    one year post surgery

  • functional test battery

    12 months

  • local wound conditions

    within 12 weeks

  • +2 more secondary outcomes

Interventions

FHL transferPROCEDURE

endoscopic transfer og flexor hallucis longus

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients With chronic Achilles Tendon Rupture

You may qualify if:

  • Chronic Achilles Tendon Rupture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

Study Officials

  • Elisabeth E Husebye, MD, PhD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 19, 2016

Study Start

December 1, 2015

Primary Completion

February 1, 2022

Study Completion

February 1, 2024

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)