Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

Study Overview
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Brief Summary
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Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.

Detailed Description
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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 (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.

Official Title
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Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

Conditions
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Calcific Tendinitis of Shoulder, Atelocollagen

Intervention / Treatment
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* Device: Tendoregen (Atelocollagen)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atelocollagen injection group<br>Atelocollagen injection | Device: Tendoregen (Atelocollagen)<br>* Tendoregen (Atelocollagen) injection<br>* Other names: Lidocain;|
| Placebo Comparator: Lidocain injection group<br>Lidocain injection | Device: Tendoregen (Atelocollagen)<br>* Tendoregen (Atelocollagen) injection<br>* Other names: Lidocain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score (Shoulder function score) | The Constant score is commonly used to evaluate the functional status of shoulder disorders and shows relatively high accuracy, reliability, and reproducibility. The evaluation is out of a total of 100 points: pain 15 points, daily activities 20 points, anterior elevation 10 points, lateral elevation 10 points, internal/external rotation each 10 points, and muscle strength 25 points | 1, 3, 5 months |