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

Hallym University Dongtan Sacred Heart Hospital

Status: Active, not recruiting

Conditions: Rotator Cuff Tear

Treatments: Procedure: Hyaluronic acid injection; Procedure: Atelo collagen injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07285746

HDT 2020-12-003

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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124 participants in 4 patient groups

Atelo collagen + HA Group

Experimental group

Description:

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

Treatment:

Procedure: Atelo collagen injection

Procedure: Hyaluronic acid injection

HA only Group

Experimental group

Description:

Patients receive injection of HA during arthroscopic rotator cuff repair

Treatment:

Procedure: Hyaluronic acid injection

Atelo collagen only Group

Experimental group

Description:

Patients receive injection of Atelo collagen during arthroscopic rotator cuff repair

Treatment:

Procedure: Atelo collagen injection

No injection Group

No Intervention group

Description:

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