NCT07285746

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Mar 2020Jun 2026

Study Start

First participant enrolled

March 2, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

December 2, 2025

Last Update Submit

February 9, 2026

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tearHealingAtelo collagenHyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • Rotator cuff healing status

    Assessed by MRI according to Sugaya classification \& cuff muscle atrophy ratio

    6 and 24 months after surgery

Secondary Outcomes (3)

  • Pain Level

    3 months, 6 months, 12 months and 2 years after surgery

  • Functional Improvement of the Shoulder

    3 months, 6 months, 12 months, and 2 years after surgery

  • Range of Motion

    3 months, 6 months, 12 months, and 2 years after surgery

Study Arms (4)

Atelo collagen + HA Group

EXPERIMENTAL

Patients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair

Procedure: Atelo collagen injectionProcedure: Hyaluronic acid injection

HA only Group

EXPERIMENTAL

Patients receive injection of HA during arthroscopic rotator cuff repair

Procedure: Hyaluronic acid injection

Atelo collagen only Group

EXPERIMENTAL

Patients receive injection of Atelo collagen during arthroscopic rotator cuff repair

Procedure: Atelo collagen injection

No injection Group

NO INTERVENTION

Patients do not receive any injections during arthroscopic rotator cuff repair.

Interventions

Atelo collagen injectionPROCEDURE

Patients receive atelocollagen injection during arthroscopic rotator cuff repair.

Atelo collagen + HA GroupAtelo collagen only Group
Hyaluronic acid injectionPROCEDURE

Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.

Atelo collagen + HA GroupHA only Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, 18450, South Korea

Location

Related Publications (7)

  • 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.

    PMID: 24720329BACKGROUND

  • 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.

    PMID: 25911388BACKGROUND

  • 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.

    PMID: 29996980BACKGROUND

  • 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.

    PMID: 32128319RESULT

  • 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.

    PMID: 28872895RESULT

  • 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.

    PMID: 28586622RESULT

  • 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.

    PMID: 31194057RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopaedics

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 16, 2025

Study Start

March 2, 2020

Primary Completion

February 28, 2023

Study Completion (Estimated)

June 30, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations

KR(1)