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Completed

NCT Number: NCT03061942

Arthroscopic Rotator Cuff Repair With Synovectomy

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

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic rotator cuff repair without synovectomy

Other

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

Arthroscopic rotator cuff repair with synovectomy

Other

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.

Primary outcomes

  1. The worst pain VAS(visual analogue scale)

    Time frame: at 3 months after surgery

    A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.

Secondary outcomes

  1. Constant-Murley score

    Time frame: at 3 months after surgery

    The 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.

  2. The average pain VAS(visual analogue scale)

    Time frame: at 3 months after surgery

    The average pain VAS(visual analogue scale) is the mean of the pain VAS at rest, at night, and with movement.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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