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

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Recruiting
CT.gov ID
NCT06059625
Collaborator
(none)
50
1
2
31.5
1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: rotatori cuff repair
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRIDGE TECNIQUE: A COMPARATIVE STUDY
Actual Study Start Date :
Apr 14, 2021
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: DOUBLE-ROW

rotatori cuff repair with double-row suture bridge technique

Procedure: rotatori cuff repair
rotatori cuff repair

Active Comparator: SINGLE-ROW

rotatori cuff repair with single-row technique

Procedure: rotatori cuff repair
rotatori cuff repair

Outcome Measures

Primary Outcome Measures

  1. radiological outcome (Sugaya score) [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) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Istituto Ortopedico Rizzoli Bologna Italy 40136

Sponsors and Collaborators

  • Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT06059625
Other Study ID Numbers:
  • CUFFIA3T
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023