Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

Shoulder Dislocation Clinical Trial

Official title:

Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535585
• Other study ID #: 1134
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: January 16, 2021

Study information

• Verified date: April 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 16, 2021
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Skeletal maturity;
• Anterior glenohumeral instability;
• Previous labral lesion without bone defects or with defects that affect no more than 20% of the anteroposterior diameter of the glenoid, as shown by MRI;
• Instability severity index score (ISIS) < 4; Non-Inclusion Criteria
• Epilepsy;
• Associated rotator cuff tear;
• Proximal humeral fracture;
• Multidirectional or posterior instability by clinical evaluation;
• Generalized ligamentous laxity by clinical evaluation;

Exclusion Criteria:

• Irreparable injury to the anterior capsule or injury to the humeral insertion of the inferior glenohumeral ligament;
• Glenoid bone defect greater than 20% of the anteroposterior diameter measured by arthroscopy;
• Rotator cuff tear found on arthroscopy;
• Abandonment of the rehabilitation program and follow-up before the first evaluation of outcomes

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Device:
• knotted anchors (SutureTak biocomposite 3.0 mm)
Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
• knotless anchors (PushLock biocomposite 2.9 mm knotless)
Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)

Locations

Country	Name	City	State
Brazil	Departamento de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (54)

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* Note: There are 54 references in all — Click here to view all references

Outcome

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