Effect of patch type atelocollagen in rotator cuff repair
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0005184
- Lead Sponsor
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
- Brief Summary
The clinical trial data collection was completed on December 29, 2022, after the final one-year follow-up of the last patient, with 26 participants in the control group (4 dropouts) and 29 in the experimental group (2 dropouts). Adverse Events: 0 cases Primary Endpoint: In the experimental group, there were 3 cases (Sugaya type IV in 2 cases, type V in 1 case), compared to 9 cases in the control group (Sugaya type IV in 7 cases, type V in 2 cases), showing a significantly lower rate of re-tear in the experimental group (p=0.048). Secondary Endpoint: There were no significant differences between the two groups in terms of range of joint motion and functional scores.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 55
?adult between 30 to 69 years old
?arthroscopic rotator cuff repair
?case confirming the medication for at least 1 week and agrreeing to maintaining the doses steady during the study
?case agreed the participation of this study and consent by him-/herself
?having the past hostory of infectious arthritis, rheumatoid arthritis, tumor, fracture
?hypersensitivity
?having a history of anaphylaxis
?case or their family faving an autoimmune disease or past history
?hypersensitive to the graft
?hypersensirive to a pig protein
?phychological problems that a researcher judged as inappropriate
?undertook an intraarticular injection of steroid or others before one month prior to the surgery
?having medication including oral steroids
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method retear rate of the rotator cuff
- Secondary Outcome Measures
Name Time Method shoulder functional scores