Skip to content

Arthroscopic Rotator Cuff Repair With Synovectomy

Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03061942
Enrollment
60
Registered
2017-02-23
Start date
2017-03-08
Completion date
2018-10-26
Last updated
2018-10-31

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

Conditions

Rotator Cuff Tears

Brief summary

The purpose of this study is to assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff repair.

Interventions

OTHERArthroscopic rotator cuff repair without synovectomy

30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.

OTHERArthroscopic rotator cuff repair with synovectomy

30 subjects will undergo arthroscopic rotator cuff repair with synovectomy. Synovectomy is an operation performed to remove inflamed synovial membrane of a joint. Arthroscopic synovectomy will be performed with the use of a shaver and a cautery device through the portals for arthroscopic rotator cuff repair.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair

Exclusion criteria

* History of shoulder surgery * Acute trauma on affected shoulder * Chronic dislocation * Pyogenic infection * Rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head * Isolated subscapularis tear * Psychiatric problems that precluded informed consent * An inability to read or write * Other serious issues that precluded participation in the study * Open surgery * Rotator cuff tear with worker's compensation claim * Refuse to participate in the study * LOM that need brisement force * Partial-thickness tear with focal full-thickness extension * Irrepairable rotator cuff tear * Subjects who, for any reason, are judged by the investigator to be inappropriate for this study, including a subject who had other severe medical condition or laboratory abnormality, or who is unable to communicate or to cooperate with the investigator

Design outcomes

Primary

MeasureTime frameDescription
The worst pain VAS(visual analogue scale)at 3 months after surgeryA 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.

Secondary

MeasureTime frameDescription
Constant-Murley scoreat 3 months after surgeryThe Constant-Murley score (CMS) is a 100-points scale composed of pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
The average pain VAS(visual analogue scale)at 3 months after surgeryThe average pain VAS(visual analogue scale) is the mean of the pain VAS at rest, at night, and with movement.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026