RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRIDGE TECNIQUE: A COMPARATIVE STUDY

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Cuff Injury, Rotator

Treatments: Procedure: rotatori cuff repair

Study type: Interventional

Funder types: Other

Identifiers

NCT06059625

CUFFIA3T

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥45 years with a diagnosis of full-thickness rotator cuff injury <2cm
• Arthroscopic rotator cuff repair surgery with single row or double row suture bridge
• Follow-up > 24 months
• Completeness of clinical-radiographic documentation
• Patients at first rotator cuff repair surgery on affected side

Exclusion criteria

• Patients with associated injuries to the affected upper limb
• Patients with neuromuscular disorders, or established psychomotor disorders
• Patients with associated injuries of the subscapularis muscle tendon
• Patients with a history of previous surgery of the affected shoulder
• Patients with massive rotator cuff injury > 2cm
• Patients with severe pathologies of other organs or apparatuses that limit competitive or recreational sports activities
• Pregnant women
• Patients who cannot undergo high-field MRI (pcs with cochlear implants, cardiac, vascular or osteoarticular magnetic, pcs with previous gunshot wounds)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

DOUBLE-ROW

Experimental group

Description:

rotatori cuff repair with double-row suture bridge technique

Treatment:

Procedure: rotatori cuff repair

SINGLE-ROW

Active Comparator group

Description:

rotatori cuff repair with single-row technique

Treatment:

Procedure: rotatori cuff repair