The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation. The most commonly used technique is the attachment of glenoid labrum-ligament complex (GLLC) with knotted anchors. In 2001, Thal introduced the concept of tissue fixation using knotless anchors and its applicability for GLLC lesions. Some researchers have published studies using knotless anchors and have compared this technique to the use of knotted anchors, demonstrating similar reconstruction of labral height and functional outcomes, while the recurrence rate is still contradictory. To date, there are no prospective randomized controlled clinical trial comparing these two techniques of GLLC repairs. The researchers aims to compare clinical outcomes and imaging evaluation of patients undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted anchors.
The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. The overall incidence of first-time dislocations requiring closed reduction is 23.1 per 100,000 people/year, with a higher incidence in males and Caucasians. Individuals with a younger age at first dislocation show a higher rate of recurrence. Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation, with similar outcomes to open repair. The technique is less aggressive because the tendon of the subscapularis does not need to be addressed, leading to shorter hospital stays, less scarring, earlier return to normal activities, and a greater postoperative range of motion. In this technique, the glenoid labrum-ligament complex (GLLC) is repaired using bone anchors that can be metallic, absorbable, or flexible. Biomechanical studies have shown that these three types of anchors are similar in terms of cyclic loading resistance and bone fixation. Absorbable anchors are most frequently used because metallic anchors can cause postoperative imaging interference in MRI study, can migrate and became loose or break, which can damage the articular cartilage. Flexible anchors when submitted to cyclic stress can produce cystic cavities in bone tissue attachment 21, and probably can lead to a failure of glenoid labrum-ligament complex suture. The most commonly used technique is the attachment of GLLC with knotted anchors. Studies have shown to perform an arthroscopic knot is challenging and can be technically difficult. The knot volume can produce friction during the shoulder movement, leading joint discomfort and cartilage damage. The quality of the soft tissue healing depend on the knot quality too. The dislocation recurrence rate with this technique ranges from 4% to 19%. In 2001, Thal introduced the concept of tissue fixation using knotless anchors and its applicability for GLLC lesions. Although this new technique had solved the difficulty of tying knots, the results regarding the GLLC suture shown more gap formation between this complex and the glenoid bone, delayed anchor loosening and postoperative arthropathy. The recurrence rate is high associated with perianchor radiolucency.The recurrence rate with this technique is as high as 23.8%. Some researchers have published studies using knotless anchors and have compared this technique to the use of knotted anchors, demonstrating similar reconstruction of labral height and functional outcomes, while the recurrence rate is still contradictory. To date, there are no prospective randomized controlled clinical trial comparing these two techniques of GLLC repairs. Our researchers aims to compare clinical outcomes and imaging evaluation of patients undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted anchors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)
Departamento de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Rowe scale
To compare, using the Rowe scale, clinical outcomes, at one year after surgery, of patients undergoing labral lesion suture using knotted anchors with those treated with knotless anchors.
Time frame: 1 year
dislocation recurrence rate
To evaluate the postoperative dislocation recurrence rate in each group of patients
Time frame: 1 year
intraoperative and postoperative complications
To ascertain intraoperative (loosening, protrusion, and breaking of material) and postoperative (infection, stiffness, and osteoarthritis) complications
Time frame: 1 year
WOSI
To compare the clinical outcomes of the two patient groups using the Western Ontario Shoulder Instability Index (WOSI).
Time frame: 1 year
ASES
To compare the clinical outcomes of the two patient groups using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).
Time frame: 1 year
Magnetic resonance imaging - LGHI
Labrum glenoid height index (LGHI) - ratio of the labral height to the glenoid height
Time frame: 1 year
Magnetic resonance imaging - Labral Slope
Labral slope - angle between the line perpendicular to the deepest point of the glenoid to the labral glenoid apex
Time frame: 1 year
Magnetic resonance imaging - Labral morphology
Labral morphology (PDW EXP sequence) with the Rondelli classification
Time frame: 1 year
Magnetic resonance imaging - Anchor resorption
Anchor resorption (T1 sequence) according to Stein et al.
Time frame: 1 year
Magnetic resonance imaging - Bone reaction
Bone reaction (T2 sequence) according to Hoffmann et al.
Time frame: 1 year
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