Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

Hyungsuk Kim

Status and phase: Enrolling; Phase 4

Conditions: Calcific Tendinitis of Shoulder; Atelocollagen

Treatments: Device: Atelocollagen

Study type: Interventional

Funder types: Other

Identifiers

NCT06040112

PC23DISV0050

Details and patient eligibility

About

Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.

Full 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 (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.

Enrollment: 46 estimated patients

Sex: All

Ages: 20 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients in whom calcification of 5mm or more is observed in plain radiographs.
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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups, including a placebo group

Atelocollagen injection group

Experimental group

Description:

Atelocollagen injection

Treatment:

Device: Atelocollagen

Lidocain injection group

Placebo Comparator group

Description:

Lidocain injection

Treatment:

Device: Atelocollagen