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Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
knotted anchors (SutureTak biocomposite 3.0 mm)
knotless anchors (PushLock biocomposite 2.9 mm knotless)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

knotted anchors

knotless anchors

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 21, 2015
Last Updated
April 2, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02535585
Brief Title
Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors
Official Title
Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
January 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
knotted anchors
Arm Type
Active Comparator
Arm Description
Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
Arm Title
knotless anchors
Arm Type
Active Comparator
Arm Description
Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)
Intervention Type
Device
Intervention Name(s)
knotted anchors (SutureTak biocomposite 3.0 mm)
Intervention Description
Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
Intervention Type
Device
Intervention Name(s)
knotless anchors (PushLock biocomposite 2.9 mm knotless)
Intervention Description
Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)
Primary Outcome Measure Information:
Title
Rowe scale
Description
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
Secondary Outcome Measure Information:
Title
dislocation recurrence rate
Description
To evaluate the postoperative dislocation recurrence rate in each group of patients
Time Frame
1 year
Title
intraoperative and postoperative complications
Description
To ascertain intraoperative (loosening, protrusion, and breaking of material) and postoperative (infection, stiffness, and osteoarthritis) complications
Time Frame
1 year
Title
WOSI
Description
To compare the clinical outcomes of the two patient groups using the Western Ontario Shoulder Instability Index (WOSI).
Time Frame
1 year
Title
ASES
Description
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
Title
Magnetic resonance imaging - LGHI
Description
Labrum glenoid height index (LGHI) - ratio of the labral height to the glenoid height
Time Frame
1 year
Title
Magnetic resonance imaging - Labral Slope
Description
Labral slope - angle between the line perpendicular to the deepest point of the glenoid to the labral glenoid apex
Time Frame
1 year
Title
Magnetic resonance imaging - Labral morphology
Description
Labral morphology (PDW EXP sequence) with the Rondelli classification
Time Frame
1 year
Title
Magnetic resonance imaging - Anchor resorption
Description
Anchor resorption (T1 sequence) according to Stein et al.
Time Frame
1 year
Title
Magnetic resonance imaging - Bone reaction
Description
Bone reaction (T2 sequence) according to Hoffmann et al.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Departamento de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

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Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

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