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

N/AActive Not RecruitingNCT07285746

Hallym University Dongtan Sacred Heart Hospital124 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

124

Conditions

Rotator Cuff Tear

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Rotator cuff healing status

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

Time frame: 6 and 24 months after surgery

Secondary Outcomes

Pain Level

Measured by Visual Analog Scale (0-10, higher score indicates worse result)

Time frame: 3 months, 6 months, 12 months and 2 years after surgery

Functional Improvement of the Shoulder

Measured by American Shoulder and Elbow Surgeons Score (0-100, higher score indicates better function)

Time frame: 3 months, 6 months, 12 months, and 2 years after surgery

Range of Motion

Measured using goniometer for forward elevation and external rotation