Comparison of clinical outcomes between spacer insertion and rotator cuff repair

Multicenter randomized prospective non-inferiority trial for the comparison of clinical outcomes between subacromial spacer insertion and rotator cuff repair for massive rotator cuff tear

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009182

Enrollment

306

Registered

2024-02-16

Start date

2023-11-27

Completion date

Unknown

Last updated

2025-05-07

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

Conditions

None listed

Interventions

Procedure/Surgery : Prospectively designed, this study will compare postoperative 1 year result between patients that used subacromial balloon spacer or complete repair via additional surgical techniq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women older than 40 years of age 2) No symptom relief despite more than 3 months of conservative treatment 3) Greater than 3 centimeters of posterosuperior cuff tear or 2.5 cm of posterosuperior cuff tear with subscapularis tear, and when they require surgical treatment. 4) No known problem with the deltoid muscle 5) Tear associated factors (anteroposterior tear size, retraction size, fatty degeneration of the infraspinatus) in the RoHI classification greater than 6 out of total 9.

Exclusion criteria

Exclusion criteria: 1) Previous surgery on the same side shoulder. 2) Concomitant osteoarthritis or history of treatment for infection in the ipsilateral shoulder. 3) Full-thickness injury of the cartilage on MRI. 4) Acute traumatic rotator cuff tear 5) Patients with less than 1 year of outpatient follow-up after surgery 6) Patients with possibility of pregnancy. 7) Pain Visual analogue scale (VAS) score greater than 3 on the contralateral shoulder. 8) Allergic to Copolymer of PLA and -e-caprolactone, ingridients of Inspace?. 9) Autoimmune disease or HIV Ab (+) 10) Those that do not consent to the study 11) Those that are participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
American Shoulder and Elbow Surgeons (ASES) score	—

Secondary

Measure	Time frame
Pain Visual analogue scale;Hospital stay duration;Surgical time;Range of motion;Retear on MRI	—

Countries

Korea, Republic of

Contacts

Public ContactJoo Han Oh

Seoul National University Bundang Hospital

ojhysy@gmail.com+82-31-787-2370

Outcome results