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

OAD Orthopaedics

Status and phase: Unknown; Phase 4

Conditions: Achilles Tendinopathy

Treatments: Procedure: Flexor Hallucis Longus Tendon transfer; Procedure: No transfer of Flexor Hallucis Longus tendon; Procedure: Transfer of the Flexor Hallucis Longus Tendon

Study type: Interventional

Funder types: Other

Identifiers

NCT01341509

GW100

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

FHL tendon transferred

Active Comparator group

Description:

Surgical group in which the FHL tendon was transferred

Treatment:

Procedure: Transfer of the Flexor Hallucis Longus Tendon

FHL tendon not transferred

Active Comparator group

Treatment:

Procedure: Flexor Hallucis Longus Tendon transfer

Procedure: No transfer of Flexor Hallucis Longus tendon