Clinical trial NCT06059625: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cuff Injury, Rotator
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: radiological outcome (Sugaya score)
timeFrame: 24 months
measure: clinical outcome (American Shoulder and Elbow Surgeons shoulder score)
timeFrame: 24 months
measure: clinical outcome (University of California and Los Angeles shoulder score)
timeFrame: 24 months
measure: clinical outcome (Costant-Murley score)
timeFrame: 24 months
measure: clinical outcome (Range Of Motion)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
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.
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.
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.