Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy

NCT06322381 | Not Yet Recruiting

• 1 other identifier: Reinsertion AT VS ZO in IAT
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insertional Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Pain assessed by the visual analogue scale.

  up to1 year post baseline

• Rate of complications

  up to1 year post baseline

Study Arms (2)

Reinsertion achilles tendon

ACTIVE COMPARATOR

Reinsertion Achilles tendon by 2-4 anchors.

Procedure: Reinsertion achilles tendon

Zadek osteotomy

ACTIVE COMPARATOR

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

Interventions

Reinsertion achilles tendon 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.

Reinsertion achilles tendon

Zadek osteotomy 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.

Zadek osteotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 21670110 BACKGROUND

• 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.

  PMID: 19188560 BACKGROUND

• 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.

  PMID: 6197416 BACKGROUND

• 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.

  PMID: 16798522 BACKGROUND

• 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.

  PMID: 25619811 BACKGROUND

• 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.

  PMID: 23669005 BACKGROUND

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

  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.

  PMID: 23819935 BACKGROUND

• 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.

  PMID: 29409230 BACKGROUND

Study Officials

• Wael Y El-adly, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

• Amr AF Mohammed, lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Abanoub HH Samaan, resident

CONTACT

01220848897; Abanobhanin@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Orthopedic department at Assiut university

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 21, 2024
• Study Start: February 16, 2025
• Primary Completion: February 16, 2025
• Study Completion: March 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share