Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

April 2, 2021 updated by: Frederico Lafraia Lobo, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-010
        • Departamento de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: knotted anchors
Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
Device: knotted anchors (SutureTak biocomposite 3.0 mm)
Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
Active Comparator: knotless anchors
Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)
Device: knotless anchors (PushLock biocomposite 2.9 mm knotless)
Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dislocation recurrence rate
Time Frame: 1 year
To evaluate the postoperative dislocation recurrence rate in each group of patients
1 year
intraoperative and postoperative complications
Time Frame: 1 year
To ascertain intraoperative (loosening, protrusion, and breaking of material) and postoperative (infection, stiffness, and osteoarthritis) complications
1 year
WOSI
Time Frame: 1 year
To compare the clinical outcomes of the two patient groups using the Western Ontario Shoulder Instability Index (WOSI).
1 year
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).
1 year
Magnetic resonance imaging - LGHI
Time Frame: 1 year
Labrum glenoid height index (LGHI) - ratio of the labral height to the glenoid height
1 year
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
1 year
Magnetic resonance imaging - Labral morphology
Time Frame: 1 year
Labral morphology (PDW EXP sequence) with the Rondelli classification
1 year
Magnetic resonance imaging - Anchor resorption
Time Frame: 1 year
Anchor resorption (T1 sequence) according to Stein et al.
1 year
Magnetic resonance imaging - Bone reaction
Time Frame: 1 year
Bone reaction (T2 sequence) according to Hoffmann et al.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

March 23, 2020

Study Completion (Actual)

January 16, 2021

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1134

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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