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Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atelocollagen injection group | Experimental | Atelocollagen injection |
|
| Lidocain injection group | Placebo Comparator | Lidocain injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atelocollagen | Device | Tendoregen (Atelocollagen) injection |
|
| 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 |
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Inclusion Criteria:
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. â‘¥ 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.
â‘§ 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eunpyeong St. Mary's Hospital, The Catholic University of Korea | Recruiting | Seoul | 03341 | South Korea |
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| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| D000070657 |
| Crystal Arthropathies |