Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

NCT06040112 | Recruiting Phase 4

• 1 other identifier: PC23DISV0050
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Calcific Tendinitis of Shoulder; Atelocollagen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Atelocollagen injection group

EXPERIMENTAL

Atelocollagen injection

Device: Atelocollagen

Lidocain injection group

PLACEBO COMPARATOR

Lidocain injection

Device: Atelocollagen

Interventions

Atelocollagen DEVICE

Tendoregen (Atelocollagen) injection

Also known as: Tendoregen

Atelocollagen injection group; Lidocain injection group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyungsuk Kim: lead

Study Sites (1)

Eunpyeong St. Mary's Hospital, The Catholic University of Korea

Seoul, 03341, South Korea

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: December 6, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)