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

Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01341509

Enrollment

Registered

2011-04-25

Start date

2011-04-30

Completion date

Unknown

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendinopathy

Keywords

Surgical Treatment of Insertional Achilles Tendinopathy

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.

Interventions

PROCEDUREFlexor Hallucis Longus Tendon transfer

The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy

PROCEDURETransfer of the Flexor Hallucis Longus Tendon

The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy

PROCEDURENo transfer of Flexor Hallucis Longus tendon

There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Statistical difference	2 years	To detect a 20% difference in clinical outcomes between the two surgical groups.

Countries

United States

Contacts

Primary ContactMarjorie L Delaney, APN

marjorie.delaney@oadortho.com630-225-2554

Backup ContactGregory P Witkowski, MD

gregory.witkowski@oadortho.com630-225-2663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026