Comparison between the effect of two minimally invasive standard surgical method (without removing apart of the transverse carpal ligament) and the surgical method along removing a part of the transverse carpal ligament longitudinally on the release of the median nerve in preventing the recurrence of carpal tunnel syndrome in orthopedic surgery.
Comparison between the effect of standard minimally invasive surgery and the surgical method along removing a part of the transverse carpal ligament longitudinally, on the release of the median nerve in the prevention of CTS recurrence.
Design
The clinical trial includes a control group and parallel, single-blind, randomized clinical groups with a sample size determined according to Cohen's formula for clinical trials and using G-power software, 52 patients. Randomization is done using block randomization method.
Settings and conduct
Patients with Moderate and severe carpal tunnel syndrome referring to the orthopedic clinic of Madani Hospital will be included in this study and they will be divided into intervention and control groups with the help of rand excel function. Patients in the intervention group will undergo standard carpal tunnel surgery along with the removal of a part of the transverse ligament. In contrast, patients in the control group will undergo a standard minimally invasive surgery. All interventions will be performed by one orthopedic surgeon. All patients will be discharged one day after surgery and will be visited periodically for 12 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with moderate to severe median nerve entrapment who have undergone physical and clinical evaluations and/or EMG diagnosis. Exclusion criteria: Patients who have previously undergone surgical treatment or have had bone fractures, blunt trauma, or sharp wrist injuries.
Intervention groups
The intervention group includes patients with carpal tunnel syndrome who will undergo standard surgery along with removing part of the transverse carpal ligament longitudinally. group. Control includes patients with carpal tunnel syndrome who will undergo standard minimally invasive surgery
Main outcome variables
Recurrence rate of carpal tunnel syndrome a year after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230317057746N1
Registration date:2023-06-20, 1402/03/30
Registration timing:prospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Hamed Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7760 8607
Email address
h.jokar@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of two minimally invasive standard surgical method (without removing apart of the transverse carpal ligament) and the surgical method along removing a part of the transverse carpal ligament longitudinally on the release of the median nerve in preventing the recurrence of carpal tunnel syndrome in orthopedic surgery.
Public title
The effect of various surgical methods in preventing the recurrence of carpal tunnel syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who comes to orthopedic clinic with carpal tunnel syndrome.
Patient who diagnosis mild to moderate compression of the median nerve.
Exclusion criteria:
Patient who has wrist surgical history.
Patient who has wrist bone fracture, blunt and sharp trauma.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used for randomization. The length of the block for each of the treatment groups is considered to be 4, that is, each block includes two people from the intervention group and two people will be from the comparison group.
Then for each of these blocks Random codes will be generated. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, eligible people will be assigned to treatment or comparison groups. This random process of selecting blocks and assigning people to The intervention and comparison groups will continue until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study will be conducted in a two-way blind. After giving complete explanations about both surgical methods and reassuring the patients, the patients will be hospitalized and undergo the procedure without knowing the type of surgery. Then, independent researchers will collect information specific to patient outcomes without knowing the group to which the patients are referred.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences