Rotator Cuff Tear
Conditions
Keywords
Rotator cuff tear, Healing, Atelo collagen, Hyaluronic acid
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.
Interventions
PROCEDUREAtelo collagen injection
Patients receive atelocollagen injection during arthroscopic rotator cuff repair.
PROCEDUREHyaluronic acid injection
Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair.
Sponsors
Hallym University Dongtan Sacred Heart Hospital
Ministry of Science and ICT, Republic of Korea
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotator cuff healing status | 6 and 24 months after surgery | Assessed by MRI according to Sugaya classification \& cuff muscle atrophy ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | 3 months, 6 months, 12 months and 2 years after surgery | Measured by Visual Analog Scale (0-10, higher score indicates worse result) |
| Functional Improvement of the Shoulder | 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) |
| Range of Motion | 3 months, 6 months, 12 months, and 2 years after surgery | Measured using goniometer for forward elevation and external rotation |
Countries
South Korea
Outcome results
None listed