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IRCT20200825048515N17 IRCT 2020-12-24 Esfahan University of Medical Sciences Comparison of two methods "ulnar nerve decompression with transposition" and "ulnar nerve decompression alone" in improving patients with cubital tunnel syndrome Comparative evaluation of the therapeutic results of two methods of ulnar nerve decompression with transposition and ulnar nerve decompression alone in patients with cubital tunnel syndrome 2020-12-07 anticipated 50 Complete https://irct.ir/trial/52840 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, due to the different use of the two surgical methods, the orthopedic assistant is aware of the type of intervention. But the patient, data collector, and data analyst will not know of the type of patient grouping. 3 Cubital Tunnel Syndrome. Intervention 1: Intervention group 1: In this group, the patient is located in a supine position, and after closing the tourniquet or Esmarch bandage, and prepping and draping the upper part of the limb. 15 cm skin cutting begins from about 5-6 cm from distal to the posterior medial epicondyle and continues to 10 cm from proximal to the medial epicondyle. After cutting the skin and opening the skin and subcutaneous tissue and protecting the antebrachial cutaneous nerve, the ulnar nerve is explored (posterior to medial intermuscular septum and anterior to the interior head of the triceps). Pressure points on the nerve are released along this path, the arcade of the structure is removed, and the ulnar nerve feeding vessels are retained as long as possible. The ulnar nerve is released and after examination for the absence of pathological lesions and adhesion of the wound, it is washed and repaired skin and under the skin and the dressing and bandage are done by bandaging from the palm crease to the top of the arm. Intervention 2: Intervention group 2: In this group, the patient is located in a supine position and after closing the tourniquet or Esmarch bandage, and prepping and draping the upper part of the limb. 15 cm skin cutting begins from about 5-6 cm from distal to the posterior medial epicondyle and continues to 10 cm from proximal to the medial epicondyle. After cutting the skin and opening the skin and subcutaneous tissue and protecting the antebrachial cutaneous nerve, the ulnar nerve is explored (posterior to medial intermuscular septum and anterior to the interior head of the triceps). Pressure points on the nerve are released along this path, the arcade of struther is removed, and the ulnar nerve feeding vessels are retained as long as possible. The ulnar nerve is released and after examination for the absence of pathological lesions and adhesion of the wound, it is washed and repaired skin and under the skin and the dressing and bandage is done by bandaging from the palm crease to the top of the arm.The ulnar nerve after the release of the abovementioned path, the entrance to the forearm by keeping the branches of the nerve to the flexor carpi ulnaris muscle and no damage to them is passed to the anterior flexor-pronator mass and under a tab of flexor and pronator group fascia, which is about 1.5 inches long and 1.5 inches wide, is placed and the tab base is in the medial direction and its lateral edge is exposed to the subcutaneous tissue. After transposition and opening of the tourniquet, homeostasis is performed well. The hemovac drain is placed, the skin and under the skin are sewn, and the dressing and bandage are applied with a bandage from the palm crease to the top of the arm. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Abolghasem Zarezadeh
Orthopedic Department, Al-Zahra Hospital, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Rashed_petro@yahoo.com Esfahan University of Medical Sciences scientific Abolghasem Zarezadeh
Orthopedic Department, Al-Zahra Hospital, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Rashed_petro@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of cubital syndrome by electromyography and nerve conduction velocity(EMG-NCV) Failure to respond to non-surgical treatments performed so far Satisfaction to participate in the study no limit no limit Both History of hand surgery History of trauma penetrating the nerves of the hand History of cervical neurosurgery G56.20 Lesion of ulnar nerve, unspecified upper limb Treatment - Surgery Treatment - Surgery Intervention group 1: In this group, the patient is located in a supine position, and after closing the tourniquet or Esmarch bandage, and prepping and draping the upper part of the limb. 15 cm skin cutting begins from about 5-6 cm from distal to the posterior medial epicondyle and continues to 10 cm from proximal to the medial epicondyle. After cutting the skin and opening the skin and subcutaneous tissue and protecting the antebrachial cutaneous nerve, the ulnar nerve is explored (posterior to medial intermuscular septum and anterior to the interior head of the triceps). Pressure points on the nerve are released along this path, the arcade of the structure is removed, and the ulnar nerve feeding vessels are retained as long as possible. The ulnar nerve is released and after examination for the absence of pathological lesions and adhesion of the wound, it is washed and repaired skin and under the skin and the dressing and bandage are done by bandaging from the palm crease to the top of the arm. Intervention group 2: In this group, the patient is located in a supine position and after closing the tourniquet or Esmarch bandage, and prepping and draping the upper part of the limb. 15 cm skin cutting begins from about 5-6 cm from distal to the posterior medial epicondyle and continues to 10 cm from proximal to the medial epicondyle. After cutting the skin and opening the skin and subcutaneous tissue and protecting the antebrachial cutaneous nerve, the ulnar nerve is explored (posterior to medial intermuscular septum and anterior to the interior head of the triceps). Pressure points on the nerve are released along this path, the arcade of struther is removed, and the ulnar nerve feeding vessels are retained as long as possible. The ulnar nerve is released and after examination for the absence of pathological lesions and adhesion of the wound, it is washed and repaired skin and under the skin and the dressing and bandage is done by bandaging from the palm crease to the top of the arm.The ulnar nerve after the release of the abovementioned path, the entrance to the forearm by keeping the branches of the nerve to the flexor carpi ulnaris muscle and no damage to them is passed to the anterior flexor-pronator mass and under a tab of flexor and pronator group fascia, which is about 1.5 inches long and 1.5 inches wide, is placed and the tab base is in the medial direction and its lateral edge is exposed to the subcutaneous tissue. After transposition and opening of the tourniquet, homeostasis is performed well. The hemovac drain is placed, the skin and under the skin are sewn, and the dressing and bandage are applied with a bandage from the palm crease to the top of the arm. Symptom improvement score. Timepoint: One month, three months, six months and one year after the intervention. Method of measurement: Modified Bishop rating system. Isfahan University of Medical Sciences Approved 2020-12-05 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)