Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

NCT02535585 | Completed

• 1 other identifier: 1134
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• dislocation recurrence rate

  1 year

• intraoperative and postoperative complications

  1 year

• WOSI

  1 year

• ASES

  1 year

• Magnetic resonance imaging - LGHI

  1 year

Study Arms (2)

knotted anchors

ACTIVE COMPARATOR

Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).

Device: knotted anchors (SutureTak biocomposite 3.0 mm)

knotless anchors

ACTIVE COMPARATOR

Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)

Device: knotless anchors (PushLock biocomposite 2.9 mm knotless)

Interventions

knotted anchors (SutureTak biocomposite 3.0 mm) DEVICE

Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).

knotted anchors

knotless anchors (PushLock biocomposite 2.9 mm knotless) DEVICE

Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)

knotless anchors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Epilepsy;
• Associated rotator cuff tear;
• Proximal humeral fracture;
• Multidirectional or posterior instability by clinical evaluation;
• Generalized ligamentous laxity by clinical evaluation;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Departamento de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (54)

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MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 28, 2015
• Study Start: February 27, 2017
• Primary Completion: March 23, 2020
• Study Completion: January 16, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

BR (1)