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Active, Not Recruiting

NCT Number: NCT07285746

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, 18450, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Atelo collagen injection

Procedure

Patients receive atelocollagen injection during arthroscopic rotator cuff repair.

Hyaluronic acid injection

Procedure

Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.

Primary outcomes

  1. Rotator cuff healing status

    Time frame: 6 and 24 months after surgery

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

Secondary outcomes

  1. 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)

  2. 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. 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

Sponsors and collaborators

Lead sponsor

Hallym University Dongtan Sacred Heart Hospital

Other

Collaborators

  • Ministry of Science and ICT, Republic of Korea

Registry information

Official study title

Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect? 2-Year Results of a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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