Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

Phase 4

Recruiting

• Conditions: Calcific Tendinitis of Shoulder; Atelocollagen
• Interventions: Device: Atelocollagen

• Registration Number: NCT06040112
• Lead Sponsor: Hyungsuk Kim

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-15
• Study Start: 2023-12-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atelocollagen injection group	Atelocollagen	Atelocollagen injection
Lidocain injection group	Atelocollagen	Lidocain injection

Primary Outcome Measures

Name	Time	Method
Constant score (Shoulder function score)	1, 3, 5 months	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

Trial Locations

Locations (1)

Eunpyeong St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of