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

Trial Summary

What is the purpose of this trial?

This trial compares two surgeries for stabilizing shoulders that frequently dislocate due to bone loss. One method moves a piece of bone and tendon, while the other uses a donor bone graft. The goal is to see which method is safer and more effective.

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 data supports the effectiveness of the treatment Anatomic Glenoid Reconstruction for shoulder dislocation?

The Latarjet procedure, which is similar to Anatomic Glenoid Reconstruction, has shown excellent results in treating shoulder dislocations, with 68% of cases rated as excellent and 21.7% as good after an 8-year follow-up. Additionally, the Anatomic Glenoid Reconstruction using distal tibial allograft has shown excellent short-term results with minimal complications, indicating its potential effectiveness. ^{1 2 3 4 5}

Is the Latarjet procedure or Anatomic Glenoid Reconstruction generally safe for humans?

The Latarjet procedure and Anatomic Glenoid Reconstruction have been shown to have minimal complication rates and are considered safe for treating shoulder instability. Studies report excellent short-term results with these procedures, and they are often used when other treatments fail, with a low risk of complications like neurovascular injuries. ^{1 3 6 7 8}

How does the Anatomic Glenoid Reconstruction treatment differ from other treatments for shoulder dislocation?

Anatomic Glenoid Reconstruction is unique because it uses an arthroscopic technique to insert a distal tibial allograft (a bone graft from a donor) through a novel portal, offering an alternative to the more invasive open Latarjet procedure. This approach aims to address glenoid bone loss while potentially reducing the technical challenges and complications associated with traditional methods. ^{1 2 5 9 10}

Research Team

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority, Orthopaedic Surgeon

Eligibility Criteria

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.

Patients with posterior shoulder instability

I have a large tear in my shoulder muscle, confirmed by MRI.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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 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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Safety of a Far Medial Arthroscopic Portal for Anatomic Glenoid Reconstruction: A Cadaveric Study. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Latarjet's surgery in recurrent anterior dislocations of the shoulder. 117 cases with an 8-year follow-up]. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Revision with Autologous Iliac Crest Bone Graft for Failed Anatomic Glenoid Reconstruction Using Distal Tibia Allograft. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between the Thickness of the Coracoid Process and Latarjet Graft Positioning-An Anatomical Study on 70 Embalmed Scapulae. [2020]

5. Brazil 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Traumatic recurrent anterior dislocation of the shoulder: two- to four-year follow-up of an anatomic open procedure. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of Failed Latarjet With Arthroscopic Anatomic Glenoid Reconstruction. [2022]

8. Turkey pubmed.ncbi.nlm.nih.gov

Modified Latarjet procedure for patients with glenoid bone defect accompanied with anterior shoulder instability. [2022]

9. England pubmed.ncbi.nlm.nih.gov

LUtarjet-limit unique coracoid osteotomy Latarjet (With video). [2022]

10. England pubmed.ncbi.nlm.nih.gov

Early outcomes of the arthroscopic Latarjet procedure in a series of 37 patients with shoulder instability. [2021]