68 Participants Needed

Latarjet Procedure vs Anatomic Glenoid Reconstruction for Shoulder Dislocation

SR
IW
Overseen ByIvan Wong, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical procedures, Latarjet and Anatomic Glenoid Reconstruction (AGR), for treating recurring shoulder dislocations. Both procedures aim to repair the glenoid bone, potentially reducing future dislocations, alleviating pain, and enhancing shoulder function. The trial evaluates the outcomes of these surgeries to determine which is more effective and has fewer complications. Individuals with one or more anterior shoulder dislocations and significant bone loss in the shoulder may qualify for this trial. As an unphased trial, it provides patients the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these surgical procedures are safe for shoulder dislocation treatment?

Research has shown that the Latarjet procedure is generally safe for individuals with shoulder instability. Most patients experience improved shoulder function and stability, with many returning to sports post-surgery. A long-term study found that 86.8% to 93.5% of patients achieved good to excellent results years later.

Studies on Anatomic Glenoid Reconstruction (AGR) also demonstrate its safety. This procedure has a safety record comparable to the Bankart repair, another common shoulder surgery. No reported cases of recurrent shoulder dislocation after AGR surgery indicate a strong safety record.

Both surgeries are well-tolerated, reducing shoulder dislocations while improving function and reducing pain. Overall, both procedures are safe options for treating shoulder instability.12345

Why are researchers excited about this trial?

Researchers are excited about the Latarjet procedure and Anatomic Glenoid Reconstruction for shoulder dislocations because they offer new surgical techniques to enhance joint stability. The Latarjet procedure uses an autograft to reinforce the glenoid, potentially providing improved strength and lessening the chance of recurrent dislocations. In contrast, the Anatomic Glenoid Reconstruction uses an allograft, which might offer better anatomical restoration of the shoulder joint, possibly leading to more natural joint function. These approaches aim to address the limitations of traditional surgeries like Bankart repair by offering potentially better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for shoulder dislocation?

This trial will compare the Latarjet procedure with Anatomic Glenoid Reconstruction (AGR) for treating shoulder instability. Studies have shown that the Latarjet procedure effectively treats shoulder instability by using a piece of bone to stabilize the shoulder joint, reducing the risk of dislocation. This method is considered a top choice due to its consistently good long-term results. In contrast, AGR is a newer technique gaining attention. It also uses bone to rebuild the shoulder joint but in a slightly different manner. Early research suggests that AGR is safe and effective, with a low risk of complications and recurrent dislocation. Both treatments in this trial aim to reduce pain and prevent future dislocations.14678

Who Is on the Research Team?

Ivan Wong, MD | Ivan Wong, MD

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority, Orthopaedic Surgeon

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced one or more anterior shoulder dislocations and show over 20% bone loss on a pre-operative CT scan. It's not suitable for those with posterior or multidirectional instability, massive rotator cuff tears, substance abuse history, or inability to consent or accept random treatment assignment.

Inclusion Criteria

My shoulder has dislocated before, and a CT scan shows I've lost over 20% of bone there.

Exclusion Criteria

I do not want to be randomly assigned to a treatment group.
I have a large tear in my shoulder muscle, confirmed by MRI.
Patients with posterior shoulder instability
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Latarjet or Anatomic Glenoid Reconstruction surgical procedure to address anterior shoulder instability with glenoid bone loss

Surgery and immediate post-operative care

Follow-up

Participants are monitored for safety, complications, and effectiveness of the surgical intervention through clinical and radiographic outcome measures

2 years
Regular follow-up visits at 1 year and 2 years post-surgery

Long-term follow-up

Participants continue to be monitored for recurrent instability and other long-term outcomes

Beyond 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Anatomic Glenoid Reconstruction
  • Latarjet
Trial Overview The study compares two surgical methods for treating recurrent shoulder dislocation due to bone loss: Latarjet procedure (coracoid transfer) versus Anatomic Glenoid Reconstruction using distal tibia allograft with Bankart repair. The goal is to assess which surgery offers better clinical and radiographic outcomes post-operation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Anatomic Glenoid ReconstructionExperimental Treatment1 Intervention
Group II: LatarjetActive Control1 Intervention

Anatomic Glenoid Reconstruction is already approved in European Union, United States for the following indications:

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Approved in European Union as Anatomic Glenoid Reconstruction for:
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Approved in United States as Anatomic Glenoid Reconstruction for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Published Research Related to This Trial

The Latarjet procedure, involving the transplantation of the coracoid process to the shoulder, was performed on 117 shoulders in 113 patients, resulting in excellent outcomes for 68% of patients and good outcomes for 21.7%, indicating its efficacy in treating recurrent anterior shoulder dislocation.
Postoperative complications were rare and generally mild, with only a few cases of osteoporosis and fractures related to the transplant, suggesting that the procedure is safe for most patients.
[Latarjet's surgery in recurrent anterior dislocations of the shoulder. 117 cases with an 8-year follow-up].Benammar, MN., Saragaglia, D., Legrand, JJ., et al.[2016]
The Congruent arc Latarjet procedure can restore larger glenoid cavity defects (up to 45.6% of the anterior segment) compared to the Classic Latarjet procedure, which can only restore about 28.4% of defects.
For glenoid cavity defects of 20% or less, the Classic Latarjet is generally sufficient, but for defects of 35% or more, the Congruent arc technique is recommended, highlighting the need for careful preoperative assessment in the 20-35% range.
Relationship between the Thickness of the Coracoid Process and Latarjet Graft Positioning-An Anatomical Study on 70 Embalmed Scapulae.Gregori, M., Eichelberger, L., Gahleitner, C., et al.[2020]
The arthroscopic Latarjet procedure combined with capsular repair effectively restored shoulder stability in 37 patients with recurrent anterior shoulder dislocation and significant glenoid bone loss, with no recurrent dislocations reported during follow-up.
Patients showed significant improvements in shoulder function, as indicated by Rowe, Walch-Duplay, and subjective shoulder value scores, with most recovering to pre-injury motion levels within 6-12 months post-surgery.
Early outcomes of the arthroscopic Latarjet procedure in a series of 37 patients with shoulder instability.Zeng, Z., Liu, C., Liu, Y., et al.[2021]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38825225/
Clinical and radiographic outcomes of primary vs. revision ...The purpose of this study was to assess the clinical and radiographic outcomes of arthroscopic anatomic glenoid reconstruction (AAGR) used for primary vs. ...
Posterior Arthroscopic Anatomic Glenoid ReconstructionThe arthroscopic anatomic glenoid reconstruction (AAGR) has been shown to be a safe and effective procedure for recurrent anterior instability of the shoulder ...
Clinical and radiographic outcomes of primary vs. revision ...The purpose of this study was to assess the clinical and radiographic outcomes of arthroscopic anatomic glenoid reconstruction (AAGR) used for primary vs. ...
Arthroscopic Anatomical Glenoid Reconstruction Using ...This technical note provides a step-by-step guide for performing arthroscopic anatomic glenoid reconstruction using an iliac crest autograft ...
Systematic review Arthroscopic anatomic glenoid ...Arthroscopic anatomic glenoid reconstruction demonstrates its safety with short-term to medium-term results for anteroinferior shoulder instability: a ...
Arthroscopic Treatment of Shoulder Instability With Glenoid ...The results of arthroscopic anterior labral repair have demonstrated high failure rates in patients with significant glenoid bone loss.
Arthroscopic Anatomic Glenoid Reconstruction ...Conclusion: AAGR demonstrates an excellent safety profile comparable to Bankart repair with no associated incidence of recurrent dislocation. AAGR graft ...
Posterior Arthroscopic Anatomic Glenoid ReconstructionThe arthroscopic anatomic glenoid reconstruction (AAGR) has been shown to be a safe and effective procedure for recurrent anterior instability ...
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