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IRCT20211207053320N1 IRCT 2022-01-27 Arak University of Medical Sciences The effect of iliotibial band tightness and its release on postoperative pain after total knee arthrplasty in patients The effect of iliotibial band tightness and its release on postoperative pain after total knee arthrplasty in patients with varusgonarthrosis 2022-01-10 anticipated 114 Complete https://irct.ir/trial/60577 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 3 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: The study is double-blind. The analysis is done by the analyst and outcome evaluator (two-blind) and the participant. Analysts, evaluators and participants are not aware of the consequences of grouping. Surgery is performed by an assistant of orthopedist. Patients are followed up and variables are reviewed by the project resident. 2-3 Knee arthroplasty. Intervention 1: Control group: If they do not have iliotibial band stiffness, they will be included in the control group.Routine surgery will be performed. Intervention 2: Intervention group: Patients are evaluated for stiffness at the end of the operation.The first group of intervention that iliotibial band will be released duration surgery.All peripheral femoral tibia osteophytes should be removed before any soft tissue is released.In tibia, release can be done with osteotomy priority. In femoral part, it is done by sharp dissection. Intervention 3: Intervention group: Patients will be evaluated for stiffness at the end of the operation. second group of intervention that iliotibial band will not be released duration surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Mohammadreza Bozorgmanesh
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 bozorgmanesh@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Hosseinali Hadi
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 hadi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) 40 years and up Patients with osteoarthritis and varus of the knee referred for knee arthroplasty Absence of underlying disease Absence of mental illness 40 years no limit Both Lack of conscious consent Death T84.9 Unspecified complication of internal orthopaedic prosthetic device, implant and graft Treatment - Surgery Treatment - Surgery Treatment - Surgery Control group: If they do not have iliotibial band stiffness, they will be included in the control group.Routine surgery will be performed. Intervention group: Patients are evaluated for stiffness at the end of the operation.The first group of intervention that iliotibial band will be released duration surgery.All peripheral femoral tibia osteophytes should be removed before any soft tissue is released.In tibia, release can be done with osteotomy priority. In femoral part, it is done by sharp dissection. Intervention group: Patients will be evaluated for stiffness at the end of the operation. second group of intervention that iliotibial band will not be released duration surgery. Pain. Timepoint: 2 weeks and one month and three months and 6 months and one year later. Method of measurement: Visual analog pain questionnaire. Joint stability. Timepoint: 2 weeks and one month and three months and 6 months and one year later. Method of measurement: International Knee Documentation Committee (IKDC). Arak University of Medical Sciences Approved 2021-11-17 Ethics Comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)