A Phase 4 interventional study of Atelocollagen in Calcific Tendinitis of Shoulder and Atelocollagen, sponsored by Hyungsuk Kim. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Hyungsuk Kim · Phase 4, Interventional, and Treatment
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.
57 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
This study's planned enrollment of 46 is below the median of 90 across 33 interventional studies indexed under Rotator Cuff Tear Arthropathy.
Browse Rotator Cuff Tear Arthropathy studies →This is the only study on the registry with Hyungsuk Kim as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.
Patients with .
Patients with a history of anaphylactic reactions.
Patients with ongoing 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 or other injection treatments within one month prior to the procedure decision.
⑨ Patients who are on concomitant medications that include oral steroids.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Atelocollagen injection
Device: Atelocollagen
Lidocain injection
Device: Atelocollagen
Tendoregen (Atelocollagen) injection
Also known as: Tendoregen
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
Time frame: 1, 3, 5 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2024, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Rotator Cuff Tear Arthropathy →