Latarjet vs Anatomic Glenoid Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorNova Scotia Health Authority
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with one or more instances of anterior shoulder dislocation; pre-operative CT scan illustrating >20% bone loss.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Coracoid Transfer
Procedure/SurgeryFor 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.
Distal Tibia Allograft with Bankart repair
Procedure/SurgeryFor 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: LatarjetActive comparator 1 intervention
Group B: Anatomic Glenoid ReconstructionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complication reporting
Complications reported any time from surgery to post-surgery will be compared.
Time frame
2 yearsSecondary outcomes
1
Recurrent Instability
The rate of recurrent instability, dislocation and/or subluxation will be compared up until 2 years following surgery.
Time frame
2 years2
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.
Time frame
1 and 2 years3
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.
Time frame
1 and 2 years4
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.
Time frame
1 and 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov