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IRCT20220809055649N1 IRCT 2023-06-01 Tehran University of Medical Sciences Teriparatide in Post-op Rotator Cuff Healing Comparison of the Effectiveness of Teriparatide and Placebo in Enhancing Rotator Cuff Tendon Healing in Patients after Rotator Cuff Arthroscopic Repair Surgery 2021-03-21 anticipated 50 Complete https://irct.ir/trial/65218 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocks of 4 are used for randomization, considering that data will be collected from two wards of Imam Khomeini Complex Hospital of Tehran are selected in the stratification factors section. For blinding, the drug manufacturing company will be asked to make a placebo, in this way, the surgeon will be provided with drugs completely similar to the original drug with blinded codes (by the pharmaceutical company) to use for the patients, randomly. Patients are also informed that they may be in the treatment or control group. At the end of the study, the statistician, having the list of blinded codes of the pharmaceutical company, will only be informed which codes are in the same group (treatment or control), Blinding description: The surgeon will be provided with drugs completely similar to the original drug with blinded codes (by the pharmaceutical company) to use for the patients, randomly. Patients are also informed that they may be in the treatment or control group. At the end of the study, the statistician, having the list of blinded codes of the pharmaceutical company, will only be informed which codes are in the same group (treatment or control). N/A Arthroscopic rotator cuff repair. Intervention 1: Intervention group: Daily use of 20 μg of rhPTH drug subcutaneously for 3 months. Intervention 2: Control group: placebo consumption for three months including mannitol, sodium acetate (anhydous wfi, 10% Glacial acetic acid, meta-cresol, Hydrochloric acid solution 10%, sodium hydroxide solution. 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 further information
public Amir Human Hoveidaei
Sports Medicine Research Center, No.7, Al-e Ahmad Highway, Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 8863 0227 hoveidaei.a.h@gmail.com Tehran University of Medical Sciences scientific Mohammadreza Guity
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 m_guity@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of rotator cuff rupture clinically and with MRI findings. Patient Informed Consent is obtained 50 years 80 years Both Refusal to participate in the study Previous shoulder surgery History of shoulder septic arthritis Patients with combined shoulder surgeries than rotator cuff repair Non-operable rotator cuff tear Contraindication in using Recombinant Human Parathyroid Hormone (rhPTH) Patients under radiation therpay Known case of any psychological disorders Pregnancy Hypo/Hyper Calcemia/Calciuria S46.0 Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder Treatment - Drugs Placebo Intervention group: Daily use of 20 μg of rhPTH drug subcutaneously for 3 months Control group: placebo consumption for three months including mannitol, sodium acetate (anhydous wfi, 10% Glacial acetic acid, meta-cresol, Hydrochloric acid solution 10%, sodium hydroxide solution Shoulder Range of Motion (Active/Passive Flexion and External Rotation). Timepoint: 6 months and 1 year. Method of measurement: Physical examination based on degrees. Post-operative pain score. Timepoint: 6 months and 1 year. Method of measurement: Visual Analogue Scale. Rotator Cuff Healing. Timepoint: 1 year. Method of measurement: By MRI evaluation via Sugaya score. Shoulder Function. Timepoint: pre-op and 1 year post-op. Method of measurement: ASES Score. Tehran University of Medical Sciences Approved 2021-01-27 Ethics committee of Imam Khomeini Hospital Complex - Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)