Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy

NCT ID: NCT06322381

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-16

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Insertional Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Reinsertion achilles tendon

Reinsertion Achilles tendon by 2-4 anchors.

Group Type ACTIVE_COMPARATOR

Reinsertion achilles tendon

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Zadek osteotomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abanoub Henen Helmy Samaan

Resident in Orthopedic department at Assiut university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wael Y El-adly, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Amr AF Mohammed, lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Abanoub HH Samaan, resident

Role: CONTACT

01220848897

References

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Scott A, Huisman E, Khan K. Conservative treatment of chronic Achilles tendinopathy. CMAJ. 2011 Jul 12;183(10):1159-65. doi: 10.1503/cmaj.101680. Epub 2011 Jun 13. No abstract available.

Reference Type BACKGROUND
PMID: 21670110 (View on PubMed)

Rees JD, Maffulli N, Cook J. Management of tendinopathy. Am J Sports Med. 2009 Sep;37(9):1855-67. doi: 10.1177/0363546508324283. Epub 2009 Feb 2.

Reference Type BACKGROUND
PMID: 19188560 (View on PubMed)

Kleinman M, Gross AE. Achilles tendon rupture following steroid injection. Report of three cases. J Bone Joint Surg Am. 1983 Dec;65(9):1345-7. No abstract available.

Reference Type BACKGROUND
PMID: 6197416 (View on PubMed)

Scholten PE, van Dijk CN. Endoscopic calcaneoplasty. Foot Ankle Clin. 2006 Jun;11(2):439-46, viii. doi: 10.1016/j.fcl.2006.02.004.

Reference Type BACKGROUND
PMID: 16798522 (View on PubMed)

McAlister JE, Hyer CF. Safety of achilles detachment and reattachment using a standard midline approach to insertional enthesophytes. J Foot Ankle Surg. 2015 Mar-Apr;54(2):214-9. doi: 10.1053/j.jfas.2014.12.009. Epub 2015 Jan 22.

Reference Type BACKGROUND
PMID: 25619811 (View on PubMed)

Rigby RB, Cottom JM, Vora A. Early weightbearing using Achilles suture bridge technique for insertional Achilles tendinosis: a review of 43 patients. J Foot Ankle Surg. 2013 Sep-Oct;52(5):575-9. doi: 10.1053/j.jfas.2012.11.004. Epub 2013 May 11.

Reference Type BACKGROUND
PMID: 23669005 (View on PubMed)

I. Zadek An operation for the cure of achillobursitis Am J Surg, 43 (1939), pp. 542-546

Reference Type BACKGROUND

Sanaei-Zadeh H, Emamhadi M, Farajidana H, Zamani N, Amirfarhangi A. Electrocardiographic manifestations in acute methanol poisoning cannot predict mortality. Arh Hig Rada Toksikol. 2013 Jun;64(2):79-85. doi: 10.2478/10004-1254-64-2013-2285.

Reference Type BACKGROUND
PMID: 23819935 (View on PubMed)

Georgiannos D, Kitridis D, Bisbinas I. Dorsal closing wedge calcaneal osteotomy for the treatment of Insertional Achilles Tendinopathy: A technical tip to optimize its results and reduce complications. Foot Ankle Surg. 2018 Apr;24(2):115-118. doi: 10.1016/j.fas.2016.12.004. Epub 2016 Dec 30.

Reference Type BACKGROUND
PMID: 29409230 (View on PubMed)

Other Identifiers

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Reinsertion AT VS ZO in IAT

Identifier Type: -

Identifier Source: org_study_id

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