An interventional study of rotatori cuff repair in Cuff Injury, Rotator, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Other
The rotator cuff is a muscle-tendon complex consisting of the tendons of the supraspinatus, subspinatus, subscapularis, and small round muscles capable of allowing movement of the shoulder joint in the various planes of space and stabilizing the glenohumeral joint.
Rotator cuff tendon injuries are very common. In most cases, these injuries are mostly degenerative based, as they are related to the aging process of the individual. However, it is increasingly common to diagnose such injuries in young individuals as well.
The reported incidence of rotator cuff injuries ranges from 5% to 40%, and of course the prevalence increases with age until it reaches 51% in patients older than 80 years.
The diagnosis of rotator cuff injury is made based on clinical examination and instrumental investigations such as Nuclear Magnetic Resonance Imaging (MRI).
Rotator cuff repair involves the use of anchors with included suture threads that allow the tendons to be returned to the level of the anatomical insertion, called the footprint.
Suture technique varies depending on the extent of injury and tendon and bone quality.
Single-row (single row) or double-row suture bridge (double-row suture bridge) anchoring techniques are currently a hotly debated topic in the literature.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
rotatori cuff repair with double-row suture bridge technique
Procedure: rotatori cuff repair
rotatori cuff repair with single-row technique
Procedure: rotatori cuff repair
rotatori cuff repair
radiological outcome (Sugaya score)
The Sugaya classification is used to evaluate rotator cuff repair, assessing post-operative rotator cuff repair on oblique coronal, oblique sagittal and transverse MRI planes. Scores range from 0 to 5 with a score of 0 indicating better tendon quality and no lesion and 5 indicating worse tendon quality with complete lesion.
Time frame: 24 months
clinical outcome (American Shoulder and Elbow Surgeons shoulder score)
ASES score is designed to assess the condition of the shoulder, regardless of disease pathology, requiring both a physician assessment and a patient-completed portion. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: 24 months
clinical outcome (University of California and Los Angeles shoulder score)
UCLA shoulder score is a jointly completed score, with both physician and patient completed portions. Scores range from 0 to 35 with a score of 0 indicating worse shoulder function and 35 indicating better shoulder function.
Time frame: 24 months
clinical outcome (Costant-Murley score)
The Costant-Murley score is designed to assess the functional state of a normal, a diseased, or a treated shoulder. It contains both physician-completed and patient-reported portions. Scores range from 0 points (most disability) to 100 points (least disability).
Time frame: 24 months
clinical outcome (Range Of Motion)
ROM expresses in degrees the degree of range of motion that a joint can perform along its full range of motion whether active or passive through an external aid.
Time frame: 24 months
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli