Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy

• ClinicalTrials.gov Identifier: NCT06322381
• Recruitment Status: Not yet recruiting
• First Posted: March 21, 2024
• Last Update Posted: April 30, 2024
• Sponsor: Assiut University
• Information provided by (Responsible Party): Abanoub Henen Helmy Samaan, Assiut University

Tracking Information

• First Submitted Date: March 7, 2024
• First Posted Date: March 21, 2024
• Last Update Posted Date: April 30, 2024
• Estimated Study Start Date: April 2024
• Estimated Primary Completion Date: April 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 19, 2024)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 19, 2024)

• 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.
• Rate of complications [ Time Frame: up to1 year post baseline ]
  Rate of complications e.g. non-union, post-operative infections

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy
• Official Title: Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy: a Randomized Controlled Trial
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Insertional Achilles Tendinopathy

Intervention

• 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.
• 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.

Study Arms

• Active Comparator: Reinsertion achilles tendon
  Reinsertion Achilles tendon by 2-4 anchors.
  Intervention: Procedure: Reinsertion achilles tendon
• 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.
  Intervention: Procedure: Zadek osteotomy

Publications *

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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 19, 2024): 42
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2025
• Estimated Primary Completion Date: April 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Abanoub HH Samaan, resident; 01220848897; Abanobhanin@med.aun.edu.eg

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06322381
• Other Study ID Numbers: Reinsertion AT VS ZO in IAT
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abanoub Henen Helmy Samaan, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Assiut University
• Verification Date: April 2024