Comparison of the Effectiveness of Teriparatide and Placebo in Enhancing Rotator Cuff Tendon Healing in Patients after Rotator Cuff Arthroscopic Repair Surgery
Determining the effect of Teriparatide on healing after arthroscopic rotator cuff repair surgery
Design
A clinical trial with the control group, with parallel groups, triple-blind, randomized, on 70 patients. The blocking method is used for randomization.
Settings and conduct
This study will be performed at Imam Khomeini Complex Hospital of Tehran. A randomized, triple-blind, control clinical trial is carried out on 70 patients. The surgeon, assessor, data statistician, and patient are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of rotator cuff rupture clinically and with MRI findings and patient informed consent obtain.
Exclusion criteria: 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 therapy; known case of any psychological disorders; pregnancy; hypo/hyper Calcemia/Calciuria.
Intervention groups
Group 1: Daily use of 20 μg of rhPTH drug subcutaneously for 3 months. Group 2: placebo consumption for three months including mannitol, sodium acetate anhydous wfi, 10% Glacial acetic acid, meta-cresol, Hydrochloric acid solution 10%, sodium hydroxide solution
Main outcome variables
Shoulder Range of Motion; Shoulder Pain Visual Analogue Score; Rotator Cuff Healing by MRI evaluation via Sugaya score; Shoulder Function via ASES Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220809055649N1
Registration date:2023-06-01, 1402/03/11
Registration timing:retrospective
Last update:2023-06-01, 1402/03/11
Update count:0
Registration date
2023-06-01, 1402/03/11
Registrant information
Name
Amir Human Hoveidaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
ah-hoveidaei@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2023-03-21, 1402/01/01
Trial completion date
2023-03-21, 1402/01/01
Scientific title
Comparison of the Effectiveness of Teriparatide and Placebo in Enhancing Rotator Cuff Tendon Healing in Patients after Rotator Cuff Arthroscopic Repair Surgery
Public title
Teriparatide in Post-op Rotator Cuff Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of rotator cuff rupture clinically and with MRI findings.
Patient Informed Consent is obtained
Exclusion criteria:
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
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini Hospital Complex - Tehran University of Medical Sciences