The effectiveness of multiple atelocollagen injection in partial thickness rotator cuff tear

Not Applicable

Terminated

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0004766
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-30
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria
1)Adults over 30 and under 70
2)Partial thickness rotator cuff tear diagnosed by imaging test (ultrasound or MRI)
3)Patients who have been treated for more than 3 months by medication or physical therapy but have not improved
4)If the concomitant medication continues to be administered during the trial, patients who have confirmed the correct prescription drug being taken within at least one week and agreed to maintain a constant amount as before injection during the study
5)patients who understand the study, agree to participate in the study, and have their own written consent

Exclusion Criteria

Exclusion Criteria
1)Patients with previous history of injection therapy within 6 weeks
2)Patients with Adhesive capsulitis
3)Full thickness rotator cuff tears diagnosed by MRI or ultrasound
4)Patients with a history of uncontrolled diabetes, infectious arthritis, rheumatoid arthritis, tumors, fractures, degenerative arthritis
5)Patients who refuse injection
6)Patients who want surgical treatment
7)Patients with hypersensitivity to collagen
8)Pregnant or lactating or planning to become pregnant
9)Patients expected to have complications because of anticoagulants therapy
10)Patients sensitive to pig protein
11)Patients with a history of radiotherapy and chemotherapy within the past 2 years (except when it is determined that collagen can be administered as judged by a clinician)
12)Patients or family members with autoimmune disease in progress or with past military service
13)Patients who are sensitive to implants
14)Any clinically significant health abnormalities that can affect the completion of the study
15)Patients deemed inappropriate for this study by the judgment of doctor such as mental illness

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
imaging study : shoulder MRI

Secondary Outcome Measures

Name	Time	Method
shoulder sonography;shoulder functional score (ASES score, Constant score, KSES score);shoulder range of motion;Pain VAS score