Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect?
NCT ID: NCT07285746
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
124 participants
INTERVENTIONAL
2020-03-02
2025-12-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Atelo collagen + HA Group
Patients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair
Atelo collagen injection
Patients receive atelocollagen injection during arthroscopic rotator cuff repair.
Hyaluronic acid injection
Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.
HA only Group
Patients receive injection of HA during arthroscopic rotator cuff repair
Hyaluronic acid injection
Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.
Atelo collagen only Group
Patients receive injection of Atelo collagen during arthroscopic rotator cuff repair
Atelo collagen injection
Patients receive atelocollagen injection during arthroscopic rotator cuff repair.
No injection Group
Patients do not receive any injections during arthroscopic rotator cuff repair.
No interventions assigned to this group
Interventions
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Atelo collagen injection
Patients receive atelocollagen injection during arthroscopic rotator cuff repair.
Hyaluronic acid injection
Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for arthroscopic surgery after an MRI confirmed a diagnosis of rotator cuff tear
* Willing to participate and provide informed consent
Exclusion Criteria
* Severe glenohumeral arthritis (Hamada grade ≥ 3)
* Neurological disorder affecting shoulder function
* Massive rotator cuff tear (Tear size ≥ 5 cm)
40 Years
75 Years
ALL
No
Sponsors
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Ministry of Science and ICT, Republic of Korea
OTHER_GOV
Hallym University Dongtan Sacred Heart Hospital
OTHER
Responsible Party
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JEUNGYEOL JEONG
Associate Professor of Orthopaedics
Locations
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Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
Countries
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References
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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.
Cunningham 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.
Walsh 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.
Kim 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.
Honda 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.
Suh 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.
Li 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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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HDT 2020-12-003
Identifier Type: -
Identifier Source: org_study_id