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Latarjet vs Anatomic Glenoid Reconstruction

Primary Purpose

Shoulder Dislocation, Bone Loss, Arthroscopy

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Coracoid Transfer
Distal Tibia Allograft with Bankart repair
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with one or more instances of anterior shoulder dislocation; pre-operative CT scan illustrating >20% bone loss. Exclusion Criteria: posterior shoulder instability; multidirectional shoulder instability; massive rotator cuff teats (MRI proven); history of substance abuse, patients unable to provide informed consent, patients refusing randomization.

Sites / Locations

  • Nova Scotia Health QEII Halifax InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Latarjet

Anatomic Glenoid Reconstruction

Arm Description

The Latarjet involves the use of a auto-graft to be fixated to the anterior portion of the glenoid to recreate the size of the glenoid.

An allograft will be used for the patients in this group, inserted through a new portal and fixed to the anterior rim of the glenoid to recreate the size of the glenoid.

Outcomes

Primary Outcome Measures

Complication reporting
Complications reported any time from surgery to post-surgery will be compared.

Secondary Outcome Measures

Recurrent Instability
The rate of recurrent instability, dislocation and/or subluxation will be compared up until 2 years following surgery.
American Shoulder and Elbow Surgeon (ASES) Assessment Form
Pain and function questionnaire for patients with shoulder injury. The scores will be out of 100, and a higher score equates to a better score.
Western Ontario Shoulder Instability (WOSI) Index
Physical symptoms, emotions, and lifestyle questionnaire specific to patients with shoulder instability. The scores will be out of 100 and a lower score equates to a better outcome.
EQ5D-5L
Includes 5 questions on mobility, self care, pain, usual activities and psychological status, a summary index is used to derive the outcomes, where a score of 1 indicates the best health. This questionnaire includes a visual analog scale, to indicate overall health out of 100. A score of 100 indicates the best health.
Radiographic measure - subscapularis muscle volume
Subscapularis muscle volume will be measured radiographically before and after surgery in millilitres.
Radiographic measure - graft resorption
Radiographic analysis of the amount of resorption seen by the graft will be analyzed. This will be measured as a percentage of the original graft size.
Radiographic measure - glenoid size
This will be the graft size before and after insertion of the graft measured in millimetres.

Full Information

First Posted
November 28, 2022
Last Updated
April 24, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT05658289
Brief Title
Latarjet vs Anatomic Glenoid Reconstruction
Official Title
Latarjet vs Anatomic Glenoid Reconstruction for Treatment of Anterior Shoulder Instability With Glenoid Bone Loss: a Prospective Multi-centre Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

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

5. Study Description

Brief Summary
Anterior shoulder dislocations occur when the humeral head translates anterior to the glenoid cause pain, stiffness, and glenoid bone loss. If left untreated, the risk of recurrence can be up to or greater than 90%. The only surgically modifiable factor to reduce the risk of recurrence is the glenoid bone loss (GBL), where surgeons have the ability to recreate the shape of the glenoid and reduce the risk of recurrent shoulder dislocations. Established boney procedures for shoulder instability include the Latarjet and free bone block procedures, such as the Anatomic Glenoid Reconstruction (AGR). The Latarjet is well known for its lower rate of recurrent instability, but raises concerns due to under-appreciated complications rates. The AGR is a newer surgical approach that has garnered attention for its low rate of recurrent instability and complication profile. Both treatments can reduce pain, increase function following surgery and reduce the risk of recurrent instability. However, these two established approaches have yet to be directly compared and studied on a larger scale. The purpose of this randomized control trial is to compare clinical and radiographic outcomes pre- and post-operatively between the Latarjet to the AGR.
Detailed Description
Anterior shoulder dislocations are painful and highly prevalent. If left untreated, rates of recurrence can be up to and greater than 90%. The risk of recurrence room is increased with younger age (< 40), male sex, hyperlaxity, participation in contact sports, and GBL. From these factors, GBL is the only modifiable factor and surgical intervention is required. Managing the bone deficiency for instances of shoulder instability has proven to be a surgical challenge. Established boney procedures for shoulder instability include the open and arthroscopic Latarjet and open and arthroscopic free bone block interventions. Latarjet is considered the gold standard for treating anterior shoulder instability with bone loss, where the coracoid process is cut and transferred with the conjoin tendon through the subscapularis. The coracoid process is then fixed to the anterior glenoid increasing glenohumeral surface area and stability by the addition of the sling effect. Latarjet has proven to result in low recurrent instability but raises concerns due to underappreciated complication rates (15-30%). The arthroscopic glenoid reconstruction (AGR) with distal tibia allograft is an arthroscopic bone block procedure that has recently garnered attention for its low rate of recurrent instability and complications, high levels of patient satisfaction and avoidance of splitting the subscapularis tendon. AGR with a distal tibia uses a new far medial portal, (i.e., Halifax portal) to avoid damaging the neurovascular or musculature while allowing for anatomic repair of the glenoid. This randomized control trial will compare the gold standard Latarjet to the AGR. This study aims to randomize 68 individuals who experience anterior shoulder instability with GBL. Through a series of clinical and radiographic outcome measures, the study investigators hypothesize the AGR group will demonstrate smaller complication rates, but remain a similar post-operative recurrence rate, and patient reported outcomes. This trial will be the first multi-centre control trial evaluating the Latarjet to the AGR for patients with critical bone loss (>20%). This research has the potential to demonstrate clinical efficacy of a procedure that is safer, more anatomic, with less damage to the subscapular muscle, and an easier revision surgery.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients that have consented to the study have a 50% chance of being randomized to 1 of 2 surgical procedures.
Masking
Participant
Masking Description
The participant will be unaware of the procedure they were randomized to until the 1-year time point.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Latarjet
Arm Type
Active Comparator
Arm Description
The Latarjet involves the use of a auto-graft to be fixated to the anterior portion of the glenoid to recreate the size of the glenoid.
Arm Title
Anatomic Glenoid Reconstruction
Arm Type
Experimental
Arm Description
An allograft will be used for the patients in this group, inserted through a new portal and fixed to the anterior rim of the glenoid to recreate the size of the glenoid.
Intervention Type
Procedure
Intervention Name(s)
Coracoid Transfer
Intervention Description
For patients randomized to the active comparator group, the coracoid process and conjoined tendon will be cut and transferred to the anterior rim of the glenoid through an incision in the subscapularis muscle.
Intervention Type
Procedure
Intervention Name(s)
Distal Tibia Allograft with Bankart repair
Intervention Description
For the experimental group, a distal tibia allograft will be prepped, cut (20mm x 10mm x 15mm), and inserted into the anterior aspect of the shoulder through a far medial portal. The distal tibia allograft will be attached to the anterior glenoid using cannulated screws. A soft tissue repair, Bankart repair, is performed above the graft.
Primary Outcome Measure Information:
Title
Complication reporting
Description
Complications reported any time from surgery to post-surgery will be compared.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Recurrent Instability
Description
The rate of recurrent instability, dislocation and/or subluxation will be compared up until 2 years following surgery.
Time Frame
2 years
Title
American Shoulder and Elbow Surgeon (ASES) Assessment Form
Description
Pain and function questionnaire for patients with shoulder injury. The scores will be out of 100, and a higher score equates to a better score.
Time Frame
1 and 2 years
Title
Western Ontario Shoulder Instability (WOSI) Index
Description
Physical symptoms, emotions, and lifestyle questionnaire specific to patients with shoulder instability. The scores will be out of 100 and a lower score equates to a better outcome.
Time Frame
1 and 2 years
Title
EQ5D-5L
Description
Includes 5 questions on mobility, self care, pain, usual activities and psychological status, a summary index is used to derive the outcomes, where a score of 1 indicates the best health. This questionnaire includes a visual analog scale, to indicate overall health out of 100. A score of 100 indicates the best health.
Time Frame
1 and 2 years
Title
Radiographic measure - subscapularis muscle volume
Description
Subscapularis muscle volume will be measured radiographically before and after surgery in millilitres.
Time Frame
1 year
Title
Radiographic measure - graft resorption
Description
Radiographic analysis of the amount of resorption seen by the graft will be analyzed. This will be measured as a percentage of the original graft size.
Time Frame
1 year
Title
Radiographic measure - glenoid size
Description
This will be the graft size before and after insertion of the graft measured in millimetres.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with one or more instances of anterior shoulder dislocation; pre-operative CT scan illustrating >20% bone loss. Exclusion Criteria: posterior shoulder instability; multidirectional shoulder instability; massive rotator cuff teats (MRI proven); history of substance abuse, patients unable to provide informed consent, patients refusing randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Wong, MD
Phone
9024737626
Email
research@drivanwong.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Remedios, MSc
Phone
9024737626
Email
research@drivanwong.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Wong, MD
Organizational Affiliation
Nova Scotia Health Authority, Orthopaedic Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health QEII Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Remedios, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Latarjet vs Anatomic Glenoid Reconstruction

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