Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect?

February 9, 2026 updated by: JEUNGYEOL JEONG, Hallym University Dongtan Sacred Heart Hospital

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?

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Hwaseong-si, South Korea, 18450
        • Hallym University Dongtan Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atelo collagen + HA Group
Patients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair
Procedure: Atelo collagen injection
Patients receive atelocollagen injection during arthroscopic rotator cuff repair.
Procedure: Hyaluronic acid injection
Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.
Experimental: HA only Group
Patients receive injection of HA during arthroscopic rotator cuff repair
Procedure: Hyaluronic acid injection
Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.
Experimental: Atelo collagen only Group
Patients receive injection of Atelo collagen during arthroscopic rotator cuff repair
Procedure: Atelo collagen injection
Patients receive atelocollagen injection during arthroscopic rotator cuff repair.
No Intervention: No injection Group
Patients do not receive any injections during arthroscopic rotator cuff repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rotator cuff healing status
Time Frame: 6 and 24 months after surgery
Assessed by MRI according to Sugaya classification & cuff muscle atrophy ratio
6 and 24 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Improvement of the Shoulder
Time Frame: 3 months, 6 months, 12 months, and 2 years after surgery
Measured by American Shoulder and Elbow Surgeons Score (0-100, higher score indicates better function)
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
Measured using goniometer for forward elevation and external rotation
3 months, 6 months, 12 months, and 2 years after surgery
Pain Level
Time Frame: 3 months, 6 months, 12 months and 2 years after surgery
Measured by Visual Analog Scale (0-10, higher score indicates worse result)
3 months, 6 months, 12 months and 2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Dongtan Sacred Heart Hospital

Collaborators

Ministry of Science and ICT, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Actual)

February 28, 2023

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDT 2020-12-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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