Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05564494 |
| Other study ID # |
50028 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2023 |
| Est. completion date |
August 31, 2025 |
Study information
| Verified date |
April 2023 |
| Source |
Nova Scotia Health Authority |
| Contact |
Matt Miller, PhD |
| Phone |
9024737626 |
| Email |
research[@]drivanwong.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome
of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the
investigators will conduct this pilot trial comparing arthroscopic Bankart repair with
arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates
and functional outcomes over a 24-month period. The feasibility objectives are: (1) to
evaluate the investigators ability to recruit patients across multiple sites and (2) to
assess study protocol adherence and ability to follow patients to 24 months. Clinical
objectives for the pilot trial are exploratory only. The investigators wish to gather means
and standard deviations for clinical outcomes to power their future definitive trial. The
objectives of the definitive trial will include a comparison of patient-reported outcomes at
the two-year post-operative time point, differences in recurrence rates, complication rates,
functional shoulder assessments, and return to work/sport.
Description:
The glenohumeral joint has the greatest range of motion of any major articulation in the
human body. This increased mobility leaves the joint vulnerable to dislocation and the
development of instability and osteoarthritis, both of which can have drastic effects on work
productivity and quality of life. Symptomatic instability following anterior glenohumeral
dislocation is especially common among young people. In patients under 20 years of age,
recurrent dislocation rates may be as high as 90%. The high incidence of recurrent
dislocation negatively affects the individual and society in general. It may limit range of
movement and can require multiple hospital visits for treatment and surgical procedures to
prevent further dislocations. Chronic instability of the joint may prevent the individual
from participating in sports and physical activity, and from returning to work, and leads to
osteoarthritis. The development of osteoarthritis in young patients is devastating and leads
to changes within the shoulder that are not easily repairable and results in the need for
early shoulder replacements which are costly for both the healthcare system and for the
patient themselves. It has been well-established in the literature that surgical management
of anterior shoulder instability provides a lower recurrence rate and better rates of return
to sport than non-operative treatment. Non-operative treatment of primary anterior shoulder
instability has been found to have a high rate of progression to arthritis at a long term
follow-up, due to recurrence.
Recurrence rates are influenced by multiple factors including age and gender of the patient,
contact sport participation, ligamentous laxity, and the bone loss both on the glenoid and
humerus. Of these factors, bone loss is the only modifiable factor. Glenoid defects, present
in 22% of patients with acute dislocations, are found in 73% of recurrent dislocations. The
management of glenoid bone deficiency in shoulder instability has been a challenge to
surgeons for many years. Anteroinferior glenoid bone loss is a significant contributor to
recurrent instability through alteration of both the glenohumeral joint contact area and
congruency of the articular surfaces. Previous researchers outlined the additive effect of
humeral and glenoid bone loss in contributing to shoulder instability and stressed the
importance of bony procedures in creating a stable shoulder, particularly for the young
active patient. For patients with large anterior glenoid defects (>25%) or other risk factors
for recurrence, bone grafting procedures, including autogenous coracoid transfer to the
anterior glenoid (i.e. Latarjet procedure) as well as iliac crest autograft and tibial
allografts (i.e. arthroscopic anatomic glenoid reconstruction (AAGR)) have been described.
These procedures have all been shown to be equally effective and reliable techniques for
treating shoulder instability.
The most common pathology in recurrent shoulder instability is anteroinferior capsulolabral
avulsion. In 1938, Bankart described the detachment of the anterior inferior labrum from the
glenoid rim as a cause of anterior instability and presented his case report of 27 patients
treated surgically. In recent years, technical advancements in arthroscopic shoulder surgery
have radically altered the treatment of anterior shoulder instability. Arthroscopic
techniques have been developed in an attempt to reduce common challenges of open repair
including wide dissection, loss of external rotation and post-operative pain. Arthroscopic
labral repair, now considered routine and reliable, is the treatment of choice for many cases
of recurrent anterior shoulder instability in North America.
Although the results of arthroscopic anterior labral repair using current techniques have
been shown to parallel results of open anterior stabilizations in most patients, it is
recognized that arthroscopic labral repair is less effective in patients with risk factors
for failure such as young age, hyperlaxity, competitive contact sport participation, and in
particular glenoid or humeral bone loss. A recently published long-term study on patient
outcomes following isolated arthroscopic Bankart repair found a high rate of recurrence and
development of arthritis at a 9-12- year follow-up. The authors state that an isolated
Bankart repair does not solve the issue of glenoid bone loss.
While bony procedures have traditionally been reserved for cases with bone loss of the
glenoid or humerus (so-called Hill-Sachs lesions), there are some regions in which surgeons
prefer this type of procedure regardless of the degree of bone loss. This is in part due to
recent findings revealing that bone loss may be underestimated by current methods of
preoperative measurement. Currently, there are three common methods used to assess bone loss.
Preoperative CT and MRI are employed to quantify bone defects, and arthroscopic evaluation
may also be used.
There is much controversy over the most accurate method of quantifying bone loss. CT
evaluation of glenoid bone loss pre-operatively has been shown to underestimate bone loss..
The absence of a validated non-invasive pre-operative imaging modality has led many surgeons
to utilize bony procedures more aggressively, despite limited findings of bone loss on
pre-operative imaging. One survey revealed that, irrespective of the types of patients and
lesions, 72% of French shoulder surgeons prefer bone block procedures for treating traumatic
recurrent anterior shoulder instability. This is in stark contrast to the findings of a large
international survey, in which 90% of shoulder surgeons in other countries preferred
arthroscopic Bankart repair. Rates of recurrence after these two techniques vary widely in
the literature, ranging from 0% to 30% for arthroscopic Bankart repair, with a mean of 9%,
and from 2% to 14% for the open Latarjet bone block procedure, with a mean of 7%.
In recent years, trends toward minimally invasive shoulder surgery along with improvements in
technology and technique have led surgeons to expand the application of arthroscopic
treatment. Techniques have been developed to treat severe instability with or without
associated bone loss using arthroscopic bone allograft and autograft augmentation. These
approaches seek to provide a nearly anatomic reconstruction of the glenohumeral joint by
treating the soft tissue and the bony lesions. Advantages of an arthroscopic approach include
smaller incisions, less disruption of the subscapularis, and the ability to evaluate the
joint for other intra-articular lesions. The view afforded by the camera may allow for more
accurate placement of the graft in the joint.
Rates of instability recurrence after Bankart and bone block procedures vary widely in the
literature, ranging from 0% to 30% for arthroscopic Bankart repair and from 2% to 14% for the
bone block procedures . A recent systematic review cites the recurrence rates for these two
procedures to be 19.5% and 8.7%, respectively. Patients with recurrent dislocations and 25%
bone loss make up the majority of instability patients, as opposed to first-time dislocators
and patients with >25% bone loss. There is no consensus on the best treatment type for
patients with recurrent anterior shoulder instability with subcritical (<25%) bone loss.
However, most of the evidence to support bone grafting over soft tissue repair in this
patient population has been retrospective, and there has been no randomized controlled trial
comparing Bankart with a bone block technique, data regarding newer arthroscopic bony glenoid
augmentation is even more limited.
While a multi-site, double-blinded-randomized controlled trial would provide the best
evidence for the preferred technique, the feasibility of such a project is unknown. The
investigators therefore propose a pilot multi-site, double-blinded randomized controlled
trial to compare the outcomes of arthroscopic Bankart repair with those of arthroscopic
Bankart repair plus bony glenoid augmentation (i.e. AAGR). The goal of this pilot is to
assess the feasibility of recruiting patients across multiple sites while adhering to study
protocols before conducting a definitive RCT which requires more resources (financial and
otherwise). Additionally, most of the data on the AAGR technique is from a single surgeon and
the investigators need to ensure that the results and outcomes are generalizable across
multiple surgeons and multiple sites.
