Clinical Trial: Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

Brief Summary:

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.


Detailed Summary:

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 t
Sponsor: University of Sao Paulo

Current Primary Outcome: Rowe scale [ Time Frame: 1 year ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • dislocation recurrence rate [ Time Frame: 1 year ]
    To evaluate the postoperative dislocation recurrence rate in each group of patients
  • intraoperative and postoperative complications [ Time Frame: 1 year ]
    To ascertain intraoperative (loosening, protrusion, and breaking of material) and postoperative (infection, stiffness, and osteoarthritis) complications
  • WOSI [ Time Frame: 1 year ]
    To compare the clinical outcomes of the two patient groups using the Western Ontario Shoulder Instability Index (WOSI).
  • ASES [ Time Frame: 1 year ]
    To compare the clinical outcomes of the two patient groups using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).
  • Magnetic resonance imaging - LGHI [ Time Frame: 1 year ]
    Labrum glenoid height index (LGHI) - ratio of the labral height to the glenoid height
  • Magnetic resonance imaging - Labral Slope [ Time Frame: 1 year ]
    Labral slope - angle between the line perpendicular to the deepest point of the glenoid to the labral glenoid apex
  • Magnetic resonance imaging - Labral morphology [ Time Frame: 1 year ]
    Labral morphology (PDW EXP sequence) with the Rondelli classification
  • Magnetic resonance imaging - Anchor resorption [ Time Frame: 1 year ]
    Anchor resorption (T1 sequence) according to Stein et al.
  • Magnetic resonance imaging - Bone reaction [ Time Frame: 1 year ]
    Bone reaction (T2 sequence) according to Hoffmann et al.


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: August 21, 2015
Date Started: November 2015
Date Completion: November 2019
Last Updated: August 25, 2015
Last Verified: August 2015