Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
NCT ID: NCT06040112
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
46 participants
INTERVENTIONAL
2023-12-06
2025-06-30
Brief Summary
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Detailed Description
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Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine and atelocollagen injection.
Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine injection."
Clinical outcomes will be assessed with functional scores on 6 months after injection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Atelocollagen injection group
Atelocollagen injection
Atelocollagen
Tendoregen (Atelocollagen) injection
Lidocain injection group
Lidocain injection
Atelocollagen
Tendoregen (Atelocollagen) injection
Interventions
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Atelocollagen
Tendoregen (Atelocollagen) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Individuals who have agreed to participate in this study and have given written consent themselves.
Exclusion Criteria
* 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.
20 Years
69 Years
ALL
Yes
Sponsors
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Hyungsuk Kim
OTHER
Responsible Party
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Hyungsuk Kim
Assistant professor
Locations
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Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Countries
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Facility Contacts
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Other Identifiers
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PC23DISV0050
Identifier Type: -
Identifier Source: org_study_id
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