Rotator Cuff TearNCT07285746
Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect?
A study testing Atelo collagen injection and Hyaluronic acid injection in people with Rotator Cuff Tear, run by Hallym University Dongtan Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to analyze the correlation between the synergistic effects of atelocollagen and hyaluronic acid (HA) in enhancing rotator cuff healing postoperatively in patients undergoing rotator cuff repair surgery.The main questions it aims to answer are: Does atelo Collagen aid in the rotator cuff… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Atelo collagen injection and Hyaluronic acid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 75 years
- Scheduled for arthroscopic surgery after an MRI confirmed a diagnosis of rotator cuff tear
- Willing to participate and provide informed consent
Who cannot join
- Previous surgery on the affected shoulder
- Severe glenohumeral arthritis (Hamada grade ≥ 3)
- Neurological disorder affecting shoulder function
- Massive rotator cuff tear (Tear size ≥ 5 cm)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450
About this study
Official title: Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect? 2-Year Results of a Randomized Controlled Trial
The purpose of this study is to analyze the correlation between the synergistic effects of atelocollagen and hyaluronic acid (HA) in enhancing rotator cuff healing postoperatively in patients undergoing rotator cuff repair surgery.The main questions it aims to answer are:
- Does atelo Collagen aid in the rotator cuff repair healing process?
- Does hyaluronic acid (HA) aid in the rotator cuff repair healing process?
- Does the combined use of atelo collagen and HA in the rotator cuff repair healing process have a synergistic effect?
Read more
The researchers will compare the use of atelo collagen and HA alone with no treatment to determine their effectiveness in rotator cuff healing.
Participants will:
- receive injections of atelo collagen or HA, either alone or in combination, during arthroscopic rotator cuff repair.
- visit the clinic for medical checkups and tests every 3 months, 6 months, 1 year, and 2 years.
- Conditions
- Rotator Cuff Tear
- Being tested
- Atelo collagen injection, Hyaluronic acid injection
- Keywords
- Rotator cuff tear, Healing, Atelo collagen, Hyaluronic acid
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atelo collagen injectionProcedure or surgery
Patients receive atelocollagen injection during arthroscopic rotator cuff repair.
Hyaluronic acid injectionProcedure or surgery
Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| Atelo collagen + HA Group | Experimental | Patients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair Receives: Procedure: Atelo collagen injection; Procedure: Hyaluronic acid injection |
| HA only Group | Experimental | Patients receive injection of HA during arthroscopic rotator cuff repair Receives: Procedure: Hyaluronic acid injection |
| Atelo collagen only Group | Experimental | Patients receive injection of Atelo collagen during arthroscopic rotator cuff repair Receives: Procedure: Atelo collagen injection |
| No injection Group | No intervention | Patients do not receive any injections during arthroscopic rotator cuff repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff healing status
Assessed by MRI according to Sugaya classification \& cuff muscle atrophy ratio
Measured: 6 and 24 months after surgery
Secondary outcomes (3)
Pain Level
Measured by Visual Analog Scale (0-10, higher score indicates worse result)
Measured: 3 months, 6 months, 12 months and 2 years after surgery
Functional Improvement of the Shoulder
Measured by American Shoulder and Elbow Surgeons Score (0-100, higher score indicates better function)
Measured: 3 months, 6 months, 12 months, and 2 years after surgery
Range of Motion
Measured using goniometer for forward elevation and external rotation
Measured: 3 months, 6 months, 12 months, and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start2 Mar 2020
- Primary completion28 Feb 2023
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Dongtan Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Responsible party
- Principal investigator, JEUNGYEOL JEONG, Hallym University Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285746
- Sponsor's protocol ID
- HDT 2020-12-003
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Weeks KD 3rd, Dines JS, Rodeo SA, Bedi A. The basic science behind biologic augmentation of tendon-bone healing: a scientific review. Instr Course Lect. 2014;63:443-50.
PubMed 24720329Cunningham G, Ladermann A, Denard PJ, Kherad O, Burkhart SS. Correlation Between American Shoulder and Elbow Surgeons and Single Assessment Numerical Evaluation Score After Rotator Cuff or SLAP Repair. Arthroscopy. 2015 Sep;31(9):1688-92. doi: 10.1016/j.arthro.2015.03.010. Epub 2015 Apr 22.
PubMed 25911388Walsh MR, Nelson BJ, Braman JP, Yonke B, Obermeier M, Raja A, Reams M. Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up. J Shoulder Elbow Surg. 2018 Sep;27(9):1553-1563. doi: 10.1016/j.jse.2018.05.003. Epub 2018 Jul 9.
PubMed 29996980Kim JH, Kim DJ, Lee HJ, Kim BK, Kim YS. Atelocollagen Injection Improves Tendon Integrity in Partial-Thickness Rotator Cuff Tears: A Prospective Comparative Study. Orthop J Sports Med. 2020 Feb 21;8(2):2325967120904012. doi: 10.1177/2325967120904012. eCollection 2020 Feb.
PubMed 32128319Honda H, Gotoh M, Kanazawa T, Ohzono H, Nakamura H, Ohta K, Nakamura KI, Fukuda K, Teramura T, Hashimoto T, Shichijo S, Shiba N. Hyaluronic Acid Accelerates Tendon-to-Bone Healing After Rotator Cuff Repair. Am J Sports Med. 2017 Dec;45(14):3322-3330. doi: 10.1177/0363546517720199. Epub 2017 Sep 5.
PubMed 28872895Suh DS, Lee JK, Yoo JC, Woo SH, Kim GR, Kim JW, Choi NY, Kim Y, Song HS. Atelocollagen Enhances the Healing of Rotator Cuff Tendon in Rabbit Model. Am J Sports Med. 2017 Jul;45(9):2019-2027. doi: 10.1177/0363546517703336. Epub 2017 Jun 6.
PubMed 28586622Li H, Chen Y, Chen S. Enhancement of rotator cuff tendon-bone healing using bone marrow-stimulating technique along with hyaluronic acid. J Orthop Translat. 2019 Jan 28;17:96-102. doi: 10.1016/j.jot.2019.01.001. eCollection 2019 Apr.
PubMed 31194057
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect? 2-Year Results of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07285746
- Acronym / sponsor ID
- HDT 2020-12-003
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff tear, Healing, Atelo collagen, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Hallym University Dongtan Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Dec 2025 (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.
The purpose of this study is to analyze the correlation between the synergistic effects of atelocollagen and hyaluronic acid (HA) in enhancing rotator cuff healing postoperatively in patients undergoing rotator cuff repair surgery.The main questions it aims to answer are:
- Does atelo Collagen aid in the rotator cuff repair healing process?
- Does hyaluronic acid (HA) aid in the rotator cuff repair healing process?
- Does the combined use of atelo collagen and HA in the rotator cuff repair healing process have a synergistic effect?
The researchers will compare the use of atelo collagen and HA alone with no treatment to determine their effectiveness in rotator cuff healing.
Participants will:
- receive injections of atelo collagen or HA, either alone or in combination, during arthroscopic rotator cuff repair.
- visit the clinic for medical checkups and tests every 3 months, 6 months, 1 year, and 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atelo collagen + HA Group | Experimental | Procedure: Atelo collagen injection, Procedure: Hyaluronic acid injectionPatients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair |
| HA only Group | Experimental | Procedure: Hyaluronic acid injectionPatients receive injection of HA during arthroscopic rotator cuff repair |
| Atelo collagen only Group | Experimental | Procedure: Atelo collagen injectionPatients receive injection of Atelo collagen during arthroscopic rotator cuff repair |
| No injection Group | No intervention | –Patients do not receive any injections during arthroscopic rotator cuff repair. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40 and 75 years
- Scheduled for arthroscopic surgery after an MRI confirmed a diagnosis of rotator cuff tear
- Willing to participate and provide informed consent
Key exclusion criteria (4 listed)
- Previous surgery on the affected shoulder
- Severe glenohumeral arthritis (Hamada grade ≥ 3)
- Neurological disorder affecting shoulder function
- Massive rotator cuff tear (Tear size ≥ 5 cm)
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 |
|---|---|---|
| Atelo collagen injectionPatients receive atelocollagen injection during arthroscopic rotator cuff repair. | Procedure or surgery | Atelo collagen + HA Group, Atelo collagen only Group |
| Hyaluronic acid injectionPatients receive hyaluronic acid injection during arthroscopic rotator cuff repair. | Procedure or surgery | Atelo collagen + HA Group, HA only Group |
Primary outcome
Rotator cuff healing status
Time frame: 6 and 24 months after surgery
Assessed by MRI according to Sugaya classification \& cuff muscle atrophy ratio
3 secondary outcomes
Pain Level
Time frame: 3 months, 6 months, 12 months and 2 years after surgery
Functional Improvement of the Shoulder
Time frame: 3 months, 6 months, 12 months, and 2 years after surgery
Range of Motion
Time frame: 3 months, 6 months, 12 months, and 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 24720329Weeks KD 3rd, Dines JS, Rodeo SA, Bedi A. The basic science behind biologic augmentation of tendon-bone healing: a scientific review. Instr Course Lect. 2014;63:443-50.
- Background: PubMed 25911388Cunningham G, Ladermann A, Denard PJ, Kherad O, Burkhart SS. Correlation Between American Shoulder and Elbow Surgeons and Single Assessment Numerical Evaluation Score After Rotator Cuff or SLAP Repair. Arthroscopy. 2015 Sep;31(9):1688-92. doi: 10.1016/j.arthro.2015.03.010. Epub 2015 Apr 22.
- Background: PubMed 29996980Walsh MR, Nelson BJ, Braman JP, Yonke B, Obermeier M, Raja A, Reams M. Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up. J Shoulder Elbow Surg. 2018 Sep;27(9):1553-1563. doi: 10.1016/j.jse.2018.05.003. Epub 2018 Jul 9.
- Results publication: PubMed 32128319Kim JH, Kim DJ, Lee HJ, Kim BK, Kim YS. Atelocollagen Injection Improves Tendon Integrity in Partial-Thickness Rotator Cuff Tears: A Prospective Comparative Study. Orthop J Sports Med. 2020 Feb 21;8(2):2325967120904012. doi: 10.1177/2325967120904012. eCollection 2020 Feb.
- Results publication: PubMed 28872895Honda H, Gotoh M, Kanazawa T, Ohzono H, Nakamura H, Ohta K, Nakamura KI, Fukuda K, Teramura T, Hashimoto T, Shichijo S, Shiba N. Hyaluronic Acid Accelerates Tendon-to-Bone Healing After Rotator Cuff Repair. Am J Sports Med. 2017 Dec;45(14):3322-3330. doi: 10.1177/0363546517720199. Epub 2017 Sep 5.
- Results publication: PubMed 28586622Suh DS, Lee JK, Yoo JC, Woo SH, Kim GR, Kim JW, Choi NY, Kim Y, Song HS. Atelocollagen Enhances the Healing of Rotator Cuff Tendon in Rabbit Model. Am J Sports Med. 2017 Jul;45(9):2019-2027. doi: 10.1177/0363546517703336. Epub 2017 Jun 6.
- Results publication: PubMed 31194057Li H, Chen Y, Chen S. Enhancement of rotator cuff tendon-bone healing using bone marrow-stimulating technique along with hyaluronic acid. J Orthop Translat. 2019 Jan 28;17:96-102. doi: 10.1016/j.jot.2019.01.001. eCollection 2019 Apr.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atelo collagen injection and Hyaluronic acid injection in people with Rotator Cuff Tear, run by Hallym University Dongtan Sacred Heart Hospital 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 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff healing status (time frame: 6 and 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285746, which also lists 7 linked publications.
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 11 Feb 2026.