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

NCT ID: NCT06059625

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cuff Injury, Rotator

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DOUBLE-ROW

rotatori cuff repair with double-row suture bridge technique

Group Type EXPERIMENTAL

rotatori cuff repair

Intervention Type PROCEDURE

rotatori cuff repair

SINGLE-ROW

rotatori cuff repair with single-row technique

Group Type ACTIVE_COMPARATOR

rotatori cuff repair

Intervention Type PROCEDURE

rotatori cuff repair

Interventions

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rotatori cuff repair

rotatori cuff repair

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

References

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Khoriati AA, Antonios T, Gulihar A, Singh B. Single Vs Double row repair in rotator cuff tears - A review and analysis of current evidence. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):236-240. doi: 10.1016/j.jcot.2019.01.027. Epub 2019 Jan 30. No abstract available.

Reference Type RESULT
PMID: 30828184 (View on PubMed)

Padua R, Padua L, Ceccarelli E, Bondi R, Alviti F, Castagna A. Italian version of ASES questionnaire for shoulder assessment: cross-cultural adaptation and validation. Musculoskelet Surg. 2010 May;94 Suppl 1:S85-90. doi: 10.1007/s12306-010-0064-9.

Reference Type RESULT
PMID: 20383686 (View on PubMed)

Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.

Reference Type RESULT
PMID: 16325080 (View on PubMed)

Other Identifiers

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CUFFIA3T

Identifier Type: -

Identifier Source: org_study_id

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