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

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02996253
• Other study ID #: 2015/16389
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: February 2024

Study information

• Verified date: March 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: February 2024
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Procedure:
• FHL transfer
endoscopic transfer og flexor hallucis longus

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Central Hospital, Fredrikstad

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score		one year after FHL transfer
Secondary	Visual Analogue Scale for Pain (VAS pain) score	patient reported outcome	3, 6 and 12 months after FHL transfer
Secondary	patient reported function score (PRFS)	patient reported Activity related disability	6, 12 months
Secondary	Magnetic resonance imagine (MRI)	FHL hypertrophy	one year post surgery
Secondary	functional test battery	jump- and strength tests	12 months
Secondary	local wound conditions	wound infection	within 12 weeks
Secondary	AOFAS hindfoot		3,6,12 months
Secondary	VISA-A		6 months after surgery