Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy

Not Applicable

Not yet recruiting

• Conditions: Insertional Achilles Tendinopathy
• Interventions: Procedure: Reinsertion achilles tendon; Procedure: Zadek osteotomy

• Registration Number: NCT06322381
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Study Start: 2025-02-16
• Primary Completion: 2025-02-16
• Last Update Posted: 2025-02-19
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reinsertion achilles tendon	Reinsertion achilles tendon	Reinsertion Achilles tendon by 2-4 anchors.
Zadek osteotomy	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.

Primary Outcome Measures

Name	Time	Method
the time needed to return to normal daily activities (functional outcome) assessed by foot and ankle outcome score.	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.

Secondary Outcome Measures

Name	Time	Method
Rate of complications	up to1 year post baseline	Rate of complications e.g. non-union, post-operative infections
Pain assessed by the visual analogue scale.	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.