Status:
RECRUITING
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Lead Sponsor:
Hyungsuk Kim
Conditions:
Calcific Tendinitis of Shoulder
Atelocollagen
Eligibility:
All Genders
20-69 years
Phase:
PHASE4
Brief Summary
Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.
Detailed Description
Suitable participants based on the selection/exclusion criteria are randomly assigned to either the case group or the control group. Consent is given right before the procedure. Case group (Atelocoll...
Eligibility Criteria
Inclusion
- Patients in whom calcification of 5mm or more is observed in plain radiographs.
- In cases where concomitant medication is administered continuously during the clinical trial period, patients who have verified the exact prescribed medication taken within the last week and agreed to maintain the same amount throughout the study period.
- Individuals who have agreed to participate in this study and have given written consent themselves.
Exclusion
- Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.
- Patients with hypersensitivity.
- Patients with a history of anaphylactic reactions.
- Patients with ongoing autoimmune diseases or a past medical history of such diseases, either in the patient or their family members.
- Patients who are allergic to transplants. ⑥ Patients who are allergic to porcine (pig) proteins.
- ⑦ Patients deemed unsuitable for this trial based on the judgment of the trial administrator, such as those with mental illnesses.
- ⑧ Patients who have received intra-articular steroid or other injection treatments within one month prior to the procedure decision.
- ⑨ Patients who are on concomitant medications that include oral steroids.
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06040112
Start Date
December 6 2023
End Date
June 1 2025
Last Update
April 12 2024
Active Locations (1)
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1
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea, 03341