search
Back to results

Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

Primary Purpose

Calcific Tendinitis of Shoulder, Atelocollagen

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tendoregen (Atelocollagen)
Sponsored by
Hyungsuk Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcific Tendinitis of Shoulder

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atelocollagen injection group

Lidocain injection group

Arm Description

Atelocollagen injection

Lidocain injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 8, 2023
Last Updated
September 13, 2023
Sponsor
Hyungsuk Kim
search

1. Study Identification

Unique Protocol Identification Number
NCT06040112
Brief Title
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Official Title
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyungsuk Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinitis of Shoulder, Atelocollagen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atelocollagen injection group
Arm Type
Experimental
Arm Description
Atelocollagen injection
Arm Title
Lidocain injection group
Arm Type
Placebo Comparator
Arm Description
Lidocain injection
Intervention Type
Device
Intervention Name(s)
Tendoregen (Atelocollagen)
Other Intervention Name(s)
Lidocain
Intervention Description
Tendoregen (Atelocollagen) injection
Primary Outcome Measure Information:
Title
Constant score (Shoulder function score)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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.
Facility Information:
Facility Name
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
03341
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyungsuk Kim, M.D. Ph.D.
Phone
01074471541
Email
tupacjr@daum.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

We'll reach out to this number within 24 hrs