Comparison of Treatment Outcomes in Patients with Insertional Achilles Tendinopathy (IAT) Using Two Osteotomy Techniques With and Without Tendon Reinsertion

To compare the treatment outcomes of patients with insertional Achilles tendinopathy using two osteotomy techniques with and without Achilles tendon reinsertion.

A controlled, parallel-group, unblinded, randomized, phase 3 clinical trial on 42 patients. The Sealed Envelope online software was used for randomization using randomized blocks.

This study will be conducted in the Orthopedics Department of Akhtar Hospital, Tehran. Patients with Achilles tendon insertion tendinopathy who meet the inclusion criteria will be enrolled and randomly assigned to two groups. In the first group, after osteotomy, the Achilles tendon is anatomically reattached to the calcaneus bone (reinsertion). In the second group, osteotomy is performed but tendon reattachment is not performed. Patients will be followed up and evaluated at 3, 6, and 9 months after surgery. Blinding was not performed in this study.

Inclusion criteria: Patients with tendinopathy at the Achilles tendon junction with symptoms of pain, swelling, and tenderness in the heel, with lateral ankle radiography, involvement of less than 50% of the Achilles tendon-calcaneus junction. Exclusion criteria: failure to refer for follow-up or unwillingness to participate in the study.

Group 1: After osteotomy, the Achilles tendon is completely separated and after tendinous debridement, the tendon is re-sutured to its anatomical location by passing a thread through the tunnel created in the calcaneus bone (reinsertion is performed). Group 2: After osteotomy and removal of excess tissue, the Achilles tendon is not re-sutured to the calcaneus bone and reinsertion is not performed.

Functional score based on AOFAS ankle–hindfoot questionnaire, pain intensity based on VAS scale

In this study, randomization is performed using block randomization with variable block sizes (2, 4, and 6 participants). The unit of randomization is individual, meaning each patient is independently assigned to one of the two treatment groups. Stratified randomization is not used in this trial. The random allocation sequence was generated using the online software Sealed Envelope. After determining the total sample size (42 participants) and specifying the possible block sizes, the allocation sequence was created and placed in sealed, opaque envelopes. On the day of surgery, these envelopes are handed to the surgeon without prior disclosure to ensure allocation concealment.

Maintaining patient privacy and confidentiality

Only information related to the study protocol, statistical analysis plan, and clinical study report will be made available to other researchers to guide future studies (and not publicly).

After publication ofthe article

Researchers, students, and professors in the field of orthopedics

For use in future research and if the source is cited.

Corresponding author Dr. Aliasghar Alamian Shahramalamian@gmail.com

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