Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy

February 15, 2025 updated by: Abanoub Henen Helmy Samaan, Assiut University

Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy: a Randomized Controlled Trial

The aim of this study is to Compare functional outcome and the recovery time of reinsertion of achilles tendon VS zadek osteotomy in insertional achilles tendinopathy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Insertional Achilles tendinopathy is characterized by chronic posterior heel pain associated with posterosuperior calcaneal exostosis or intratendinous ossification. The etiologies include retrocalcaneal exostosis, the diseased tendon, enthesopathy, and Haglund's deformity. The nonsurgical therapies, such as physical therapy, stretching and strengthening of the gastrocnemius-soleus muscle complexes, nonsteroid anti-inflammatory drugs, and footwear modifications, are chosen as the initial treatment. Local injection of the steroid is not recommended because it might lead to increase risk of tendon rupture.

Surgical intervention is a suitable option when conservative treatment for more than 6 months has failed. Open detachment with reattachment of the Achilles tendon is a common surgery combined with calcaneoplasty and debridement of the retrocalcaneal bursitis and pathologic Achilles tendon. Suture techniques using bone anchors have been described to reattach the Achilles tendon with excellent results. percutaneous Osteotomy is another option, first described by Zadek in 1939 which was later modified in 1965. zadek osteotomy is a dorsal closing wedge calcaneal osteotomy that allows the tuberosity of Haglund deformity to be brought forward. This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the AT. The rationale of a ZO was to reduce the impingement between the anterior aspect of the Achilles tendon and the superior angle of the posterior calcaneal tuberosity. By shortening the calcaneus and altering the orientation of the Achilles tendon fibers it is believed to decrease stress across the tendon at its insertion.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age range 18 - 65
  • Insertional Achilles tendinopathy without steroid injection, infection, tendon rupture and ankle fracture

Exclusion Criteria:

  • Age < 18 years, > 65
  • General medical contraindications to surgical interventions
  • Calcaneal Fracture, subtalar fusion
  • infection.
  • Pathological tendon rupture
  • History of steroid injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reinsertion achilles tendon
Reinsertion Achilles tendon by 2-4 anchors.
Procedure: Reinsertion achilles tendon
Prone position, tourniquet over the thigh, direct midline incision, 2.0 cm proximal the insertion of the Achilles tendon up to 4.0 cm prolonged distal to the insertion is recommended. This is followed by a totally disinsertion of TA. At least a debridement of inflammatory or necrotic tissue as well as the removal of bony tissue is performed. tendon is re-inserted by 2-4 anchors.
Active Comparator: Zadek osteotomy
A calcaneal osteotomy was then performed, two Kirschner wires, were then inserted from the posterior aspect of the calcaneus, over which cannulated screws were used for fixation of the osteotomy.
Procedure: Zadek osteotomy
lateral position, under spinal anesthesia, tourniquet over the thigh, oblique lateral heel incision starting just anterior to the Achilles tendon, at a 45 angle to the long axis of the calcaneus posterior to the course of the sural nerve. A calcaneal osteotomy was then performed, two Kirschner wires, were then inserted from the posterior aspect of the calcaneus, over which cannulated screws were used for fixation of the osteotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time needed to return to normal daily activities (functional outcome) assessed by foot and ankle outcome score.
Time Frame: up to1 year post baseline
foot and ankle outcome score is a tool to measure the symptoms, stiffness, pain, function, daily living, sports and recreational activities of foot and ankle problems. It is based on 100 questions and ranges from 0 to 100, with higher scores indicating more severe symptoms or limitations.
up to1 year post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessed by the visual analogue scale.
Time Frame: up to1 year post baseline
The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image. The VAS is used to assist individuals to determine pain levels, who may not be accustomed to rating their pain on other types of scales, such as a numeric rating scale.
up to1 year post baseline
Rate of complications
Time Frame: up to1 year post baseline
Rate of complications e.g. non-union, post-operative infections
up to1 year post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Wael Y El-adly, professor, Assiut University
  • Study Director: Amr AF Mohammed, lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 16, 2025

Primary Completion (Estimated)

February 16, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reinsertion AT VS ZO in IAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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