Calcific Tendinitis of ShoulderPhase 4NCT06040112
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
A Phase 4 study testing Atelocollagen in people with Calcific Tendinitis of Shoulder and Atelocollagen, run by Hyungsuk Kim at 1 site in South Korea.
Trial summary
Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Calcific Tendinitis of Shoulder, Atelocollagen
- What is being tested?
- Atelocollagen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2023to Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Seoul, 03341
Hyungsuk Kim, M.D. Ph.D., 01074471541, tupacjr@daum.net
About this study
Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.
Read the 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.
- Conditions
- Calcific Tendinitis of Shoulder, Atelocollagen
- Being tested
- Atelocollagen
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtelocollagenDevice
Also called Tendoregen
Tendoregen (Atelocollagen) injection
| Study group | Role | What they receive |
|---|---|---|
| Atelocollagen injection group | Experimental | Atelocollagen injection Receives: Device: Atelocollagen |
| Lidocain injection group | Placebo comparator | Lidocain injection Receives: Device: Atelocollagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1, 3, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start6 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcific Tendinitis of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyungsuk Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyungsuk Kim, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040112
- Sponsor's protocol ID
- PC23DISV0050
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
- ClinicalTrials.gov ID
- NCT06040112
- Acronym / sponsor ID
- PC23DISV0050
- Conditions
- Calcific Tendinitis of Shoulder, Atelocollagen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hyungsuk KimUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atelocollagen injection group | Experimental | Device: AtelocollagenAtelocollagen injection |
| Lidocain injection group | Placebo comparator | Device: AtelocollagenLidocain injection |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtelocollagenAlso: TendoregenTendoregen (Atelocollagen) injection | Device | Atelocollagen injection group, Lidocain injection group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atelocollagen in people with Calcific Tendinitis of Shoulder and Atelocollagen, run by Hyungsuk Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant score (Shoulder function score) (time frame: 1, 3, 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.