Effect of patch type atelocollagen in rotator cuff repair

Effect of patch type atelocollagen in subjects with arthroscopic rotator cuff repair

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005184

Enrollment

Registered

2020-06-30

Start date

2020-11-17

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : After knotting a medial row in the arthroscopic rotator cuff repair, a patch type atelocollagen (RegenSeal, 30 x 40 x 5 mm) is inserted between the cuff and the tuberosity in the atel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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

Design outcomes

Primary

Measure	Time frame
retear rate of the rotator cuff	—

Secondary

Measure	Time frame
shoulder functional scores	—

Countries

Korea, Republic of

Contacts

Public ContactHyun Seok Song

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

hssongmd@hanmail.net+82-2-2030-4628

Outcome results