Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

April 10, 2024 updated by: Hyungsuk Kim
Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03341
        • Recruiting
        • Eunpyeong St. Mary's Hospital, The Catholic University of Korea
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atelocollagen injection group
Atelocollagen injection
Device: Atelocollagen
Tendoregen (Atelocollagen) injection
Other Names:
  • Tendoregen
Placebo Comparator: Lidocain injection group
Lidocain injection
Device: Atelocollagen
Tendoregen (Atelocollagen) injection
Other Names:
  • Tendoregen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant score (Shoulder function score)
Time Frame: 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
1, 3, 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyungsuk Kim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC23DISV0050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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