A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon

Phase 4

• Conditions: Achilles Tendinopathy
• Interventions: Procedure: Transfer of the Flexor Hallucis Longus Tendon; Procedure: Flexor Hallucis Longus Tendon transfer; Procedure: No transfer of Flexor Hallucis Longus tendon

• Registration Number: NCT01341509
• Lead Sponsor: OAD Orthopaedics

Brief Summary

The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-22
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male and female 18 years or older

• Diagnosed with insertional Achilles tendinosis by history and physical exam

• Confirmed by x-ray and MRI

• Calcification at the Achilles insertion and gastrocnemius tightness.

• Failure of the following non-operative treatment for greater than 6 months: *shoe modifications

  • physical therapy
  • immobilization
  • and home exercise program.

• In addition, participant must have an intact flexor hallucis longus tendon.

Exclusion Criteria

• Patients who have failed surgery for the same and patients with diabetic neuropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FHL tendon transferred	Transfer of the Flexor Hallucis Longus Tendon	Surgical group in which the FHL tendon was transferred
FHL tendon not transferred	Flexor Hallucis Longus Tendon transfer	-
FHL tendon not transferred	No transfer of Flexor Hallucis Longus tendon	-

Primary Outcome Measures

Name	Time	Method
Statistical difference	2 years	To detect a 20% difference in clinical outcomes between the two surgical groups.

Trial Locations

Locations (1)

OAD Orthopaedics; 🇺🇸 Warrenville, Illinois, United States