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

Primary Purpose

Cuff Injury, Rotator

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
rotatori cuff repair
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cuff Injury, Rotator

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • IRCCS Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DOUBLE-ROW

SINGLE-ROW

Arm Description

rotatori cuff repair with double-row suture bridge technique

rotatori cuff repair with single-row technique

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT06059625
Brief Title
RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRIDGE TECNIQUE: A COMPARATIVE STUDY
Official Title
RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRIDGE TECNIQUE: A COMPARATIVE STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cuff Injury, Rotator

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DOUBLE-ROW
Arm Type
Experimental
Arm Description
rotatori cuff repair with double-row suture bridge technique
Arm Title
SINGLE-ROW
Arm Type
Active Comparator
Arm Description
rotatori cuff repair with single-row technique
Intervention Type
Procedure
Intervention Name(s)
rotatori cuff repair
Intervention Description
rotatori cuff repair
Primary Outcome Measure Information:
Title
radiological outcome (Sugaya score)
Description
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
Title
clinical outcome (American Shoulder and Elbow Surgeons shoulder score)
Description
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
Title
clinical outcome (University of California and Los Angeles shoulder score)
Description
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
Title
clinical outcome (Costant-Murley score)
Description
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
Title
clinical outcome (Range Of Motion)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulio Maria Marcheggiani Muccioli, MD PhD
Phone
0516366
Ext
122
Email
giuliomaria.marcheggianimuccioli@ior.it
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Maria Marcheggiani Muccioli, MD, PhD
Phone
+39 051 6366509
Email
marcheggianimuccioli@me.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30828184
Citation
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. Erratum In: J Clin Orthop Trauma. 2020 Nov-Dec;11(6):1169-1171. J Clin Orthop Trauma. 2020 Nov-Dec;11(6):1177. J Clin Orthop Trauma. 2020 Nov-Dec;11(6):1172-1174. J Clin Orthop Trauma. 2021 Aug 05;21:101557.
Results Reference
result
PubMed Identifier
20383686
Citation
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.
Results Reference
result
PubMed Identifier
16325080
Citation
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.
Results Reference
result

Learn more about this trial

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

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