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Completed

NCT Number: NCT06059625

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

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.

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Key information

Conditions

Cuff Injury, Rotator Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

rotatori cuff repair

Procedure

rotatori cuff repair

Primary outcomes

  1. radiological outcome (Sugaya score)

    Time frame: 24 months

    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.

  2. clinical outcome (American Shoulder and Elbow Surgeons shoulder score)

    Time frame: 24 months

    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.

  3. clinical outcome (University of California and Los Angeles shoulder score)

    Time frame: 24 months

    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.

  4. clinical outcome (Costant-Murley score)

    Time frame: 24 months

    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).

  5. clinical outcome (Range Of Motion)

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
Jun 18, 2024

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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