Comparison of retear rate after rotator cuff repair according to injection of bone marrow aspirate concentrate

Comparison of retear rate after rotator cuff repair according to injection of bone marrow aspirate concentrate - Prospective, Double-blinded, Randomized Multicenter Clinical Trial -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007825

Enrollment

144

Registered

2022-10-19

Start date

2022-12-01

Completion date

Unknown

Last updated

2022-11-28

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, Biological/Vaccine, Stem Cell : After arthroscopic rotator cuff repair, the component which is randomly allocated will be applied with syringe on bone-tendon interface. For control gro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Among patients aged 19 or older, patients who will undergo surgery due to rotator cuff tear at participating institutions (Seoul National University Bundang Hospital, Seoul National University Hospital, and Konkuk University Hospital) in this study. (2) Patients with rotator cuff tear size more than 2.5 cm on preoperative magnetic resonance imaging.

Exclusion criteria

Exclusion criteria: (1) Patients with the history of surgery on the rotator cuff on the ipsilateral shoulder (2) Patients with the history of trauma on the ipsilateral shoulder (3) Patients with the history of infection (or surgery due to infection) on the ipsilateral shoulder (4) Patients with the history of fracture (or surgery due to infection) on the ipsilateral shoulder (5) Patients with the history of proliferative treatment or treatment with corticosteroid, atelocollagen, or polydeoxyribonucleotide on the ipsilateral shoulder within three months of surgery (6) Patients who decide not to participate in this study after sufficient explanation from the participating researchers (7) If additional operation will be done due to the suture anchor breakage or pull-out during the surgery, such as bone cement filling or buddy anchor insertion.

Design outcomes

Primary

Measure	Time frame
Retear rate	—

Secondary

Measure	Time frame
Functional score{American Shoulder and Elbow Surgeons Score (ASES), Simple shoulder test (SST), Constant-Murley Score (CMS)};Pain VAS;Range of motion (Forward flexion, external rotation, and internal rotation)	—

Countries

Korea, Republic of

Contacts

Public ContactYoo-Sun Won

Seoul National University Bundang Hospital

wys0199@gmail.com+82-31-787-1187

Outcome results