Latarjet Procedure vs Anatomic Glenoid Reconstruction for Shoulder Dislocation

Overseen By Ivan Wong, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Substance abuse, Informed consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate post-operative care

68 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

Who Is on the Research Team?

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

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?

Group I: Anatomic Glenoid Reconstruction Experimental Treatment 1 Intervention

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.

Group II: Latarjet Active Control 1 Intervention

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.

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

Approved in European Union as Anatomic Glenoid Reconstruction for:

• Anterior shoulder instability
• Glenoid bone loss

Approved in United States as Anatomic Glenoid Reconstruction for:

• Recurrent shoulder dislocations
• Glenoid bone loss

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The far medial arthroscopic portal for anatomic glenoid reconstruction shows minimal risk to critical neurovascular structures, with the musculocutaneous and axillary nerves being safely distanced from the portal, based on a study of 10 cadaveric shoulder specimens.

The only structure at potential risk is the cephalic vein, indicating that this technique may be a safer alternative for patients with anterior shoulder instability and significant bone loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of a Far Medial Arthroscopic Portal for Anatomic Glenoid Reconstruction: A Cadaveric Study. Moga, I., Konstantinidis, G., Wong, IH.[2022]

The study presents a detailed method for arthroscopic anatomic glenoid reconstruction using a distal tibial allograft and screw fixation, specifically for patients with significant glenoid bone loss after a failed Latarjet procedure.

This technique aims to provide a reliable and replicable solution to reduce the high incidence of recurrent shoulder dislocations following surgical interventions for anterior shoulder instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Failed Latarjet With Arthroscopic Anatomic Glenoid Reconstruction. Hewins, B., Wong, I.[2022]

The Latarjet procedure remains the gold standard for treating anterior shoulder instability with significant bone loss, but recent techniques like arthroscopic anatomic glenoid reconstruction (AAGR) using distal tibial allograft show promising short-term results and low complication rates.

Revision arthroscopic techniques using iliac crest autograft for failed AAGR procedures are technically easier than for Latarjet procedures, as they allow for better identification of anatomical landmarks and reduce the risk of neurovascular injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Revision with Autologous Iliac Crest Bone Graft for Failed Anatomic Glenoid Reconstruction Using Distal Tibia Allograft. John, R., Coady, CM., Wong, I.[2020]

In a study of 23 patients with recurrent shoulder instability, a modified open stabilization procedure resulted in no subsequent dislocations and allowed all patients to return to full working capacity after 36 months.

The procedure demonstrated excellent outcomes in shoulder stability and function, with minimal loss in range of motion and no signs of osteoarthritis, indicating its effectiveness for managing traumatic anterior glenohumeral instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic recurrent anterior dislocation of the shoulder: two- to four-year follow-up of an anatomic open procedure. Jolles, BM., Pelet, S., Farron, A.[2019]

The modified Latarjet technique, named 'LUtarjet', preserves the coracoacromial arch while effectively treating recurrent anterior shoulder dislocation in 27 patients, showing significant functional improvement after an average follow-up of 8.1 months.

This technique demonstrated a quick surgical duration of about 55.6 minutes with no reported complications, indicating it is a safe and efficient option for patients with glenoid bone loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LUtarjet-limit unique coracoid osteotomy Latarjet (With video). Deng, Z., Long, Z., Lu, W.[2022]

The modified Latarjet procedure effectively treated glenoid bone defects and anterior shoulder instability in 35 patients, resulting in significant improvements in shoulder function and pain relief, as evidenced by increased ASES and Rowe scores and decreased VAS scores post-surgery.

All patients achieved osseous union of the coracoid graft with no reported cases of degenerative arthritis or ongoing instability, indicating the procedure's safety and efficacy over an average follow-up period of 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Latarjet procedure for patients with glenoid bone defect accompanied with anterior shoulder instability. Atalar, AC., Bilsel, K., Eren, I., et al.[2022]

The Latarjet procedure was performed on 26 male patients with significant bone loss in the shoulder, resulting in statistically significant improvements in clinical outcomes as measured by the UCLA and Rowe scales (P < 0.001).

Despite some limitations in range of motion on the operated side, the procedure effectively addresses severe erosion of the glenoid margin, with no correlation found between lateral rotation limitations and the presence of arthrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RESULTS FROM LATARJET SURGERY FOR TREATING TRAUMATIC ANTERIOR SHOULDER INSTABILITY ASSOCIATED WITH BONE EROSION IN THE GLENOID CAVITY, AFTER MINIMUM FOLLOW-UP OF ONE YEAR. Ikemoto, RY., Murachovisky, J., Nascimento, LG., et al.[2022]

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