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

Active, not recruiting

• Conditions: Achilles Tendon Rupture

• Registration Number: NCT02996253
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2022-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway