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

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02996253
• Collaborator: Central Hospital, Fredrikstad (Other)
• Enrollment: 40
• Location: 1
• Duration (Months): 98
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture	Procedure: FHL transfer

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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endoscopic Assisted Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture. A Prospective Multi Center Cohort Study
• Study Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 1, 2024

Outcome Measures

Primary Outcome Measures

1. The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score [one year after FHL transfer]

Secondary Outcome Measures

1. Visual Analogue Scale for Pain (VAS pain) score [3, 6 and 12 months after FHL transfer]

   patient reported outcome

2. patient reported function score (PRFS) [6, 12 months]

   patient reported Activity related disability

3. Magnetic resonance imagine (MRI) [one year post surgery]

   FHL hypertrophy

4. functional test battery [12 months]

   jump- and strength tests

5. local wound conditions [within 12 weeks]

   wound infection

6. AOFAS hindfoot [3,6,12 months]

7. VISA-A [6 months after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0450

Sponsors and Collaborators

• Oslo University Hospital
• Central Hospital, Fredrikstad

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elisabeth Ellingsen Husebye, MD, PhD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT02996253
• Other Study ID Numbers: 2015/16389
• First Posted: Dec 19, 2016
• Last Update Posted: Mar 4, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Rupture

Study Results

No Results Posted as of Mar 4, 2021