Shoulder Surgery for Shoulder Dislocation

(ATRASI Trial)

Overseen By Sara Sparavalo, MASc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Diabetes, Prior shoulder surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of surgeries to address repeated shoulder dislocations, a condition where the shoulder frequently slips out of place. It compares the outcomes of bone graft surgery, known as anatomic glenoid reconstruction, with the standard Bankart repair surgery. Individuals who have experienced shoulder dislocation at least twice may be suitable candidates for this study. The trial aims to determine which surgery provides better shoulder function and reduces future dislocations. Researchers will closely monitor participants to assess the effectiveness of the surgeries and their recovery over time. As an unphased trial, this study offers participants the chance to contribute to important 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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical techniques are safe for treating shoulder instability?

A previous study found that arthroscopic anatomic glenoid reconstruction, a type of shoulder surgery, is safe in the short to medium term. The study reported no cases of shoulder dislocation, suggesting the procedure is generally well-tolerated.

For arthroscopic Bankart repair, research showed a low complication rate of 0.67%. The most common issue was a frozen shoulder, occurring in about 0.32% of cases, while ongoing pain affected 0.17% of patients. However, 77.6% of individuals returned to sports, indicating that most recover well.

Both treatments have been studied and are generally safe, though some risks exist. Discussing options with a doctor is important to determine the best course of action. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to addressing shoulder dislocation. Anatomic Glenoid Reconstruction uses an arthroscopic distal tibia bone graft, which provides a novel way to restore joint stability by utilizing a patient's own bone material, potentially improving integration and reducing rejection risks. On the other hand, Arthroscopic Bankart Repair is a less invasive procedure that directly repairs the torn labrum, offering quicker recovery times compared to traditional open surgeries. Both methods aim to enhance stability and function while minimizing recovery time and long-term complications, making them promising alternatives to existing treatments.

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

This trial will compare two treatments for shoulder instability: arthroscopic anatomic glenoid reconstruction (AAGR) and arthroscopic Bankart repair. Research has shown that AAGR, which uses a bone graft to rebuild the shoulder, is promising, with excellent results and a low chance of shoulder dislocation recurrence. This procedure is also considered safe, making it a reliable treatment option. Meanwhile, the arthroscopic Bankart repair effectively manages shoulder instability, allowing many to return to their activities with few complications. However, some research suggests it might have a higher chance of recurrence in the long run compared to other methods. Overall, both treatments are effective, but AAGR might offer better long-term stability. ^{1 4 6 7 8}

Who Is on the Research Team?

Ivan H Wong, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced at least two documented shoulder dislocations. It's not suitable for those with multidirectional instability, pregnancy, paralysis of the shoulder, cancer, severe systemic illness, uncontrolled diabetes (Hgb A1C >7%), previous surgery on the affected shoulder or posterior instability.

Inclusion Criteria

My shoulder has dislocated forward two or more times.

Exclusion Criteria

Multidirectional instability

Posterior instability

I have paralysis in my shoulder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Routine radiographs, CT, and MRI are obtained; baseline data and questionnaires are collected

1-2 weeks

Surgical Treatment

Participants undergo either arthroscopic Bankart repair or anatomic glenoid reconstruction

1 day

Postoperative Rehabilitation

Standardized rehabilitation protocol including immobilization and staged recovery

6 months

Follow-up at 2 weeks, 6 weeks, 3 months, 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up at 12 and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Anatomic Glenoid Reconstruction
• Arthroscopic Bankart Repair

Trial Overview The study compares two arthroscopic treatments for recurrent anterior shoulder instability: anatomic glenoid reconstruction with bone graft versus Bankart repair. The effectiveness will be measured using WOSI scores and rates of re-dislocation/subluxation among other factors in a randomized controlled setting.

How Is the Trial Designed?

Group I: Anatomic Glenoid Reconstruction Experimental Treatment 1 Intervention

Arthroscopic distal tibia bone graft

Group II: Bankart repair Active Control 1 Intervention

Arthroscopic bankart repair

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 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]

In a study of 50 patients undergoing Bankart reconstruction for recurrent shoulder instability, 94% regained normal stability after 3 years, indicating high efficacy of the modified procedure using suture anchors.

The functional outcomes were satisfactory in 86% of patients, with no specific complications related to the modified technique, suggesting it is a safe and effective option for treating shoulder instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of Bankart lesions with a suture anchor in recurrent dislocation of the shoulder. Karlsson, J., Järvholm, U., Swärd, L., et al.[2019]

In a study of 174 patients with recurrent anterior shoulder instability, the Arthroscopic Anatomic Glenoid Reconstruction (AAGR) showed a significantly lower rate of frank dislocations (0%) compared to the Arthroscopic Bankart Repair (ABR) group, which had a rate of 11%.

The overall complication rate was lower for AAGR (12%) compared to ABR (35%), suggesting that AAGR may be a safer and more effective first-line treatment option for certain patients, particularly younger athletes with a history of instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic anatomic glenoid reconstruction has a lower rate of recurrent instability compared to arthroscopic Bankart repair while otherwise maintaining a similar complication and safety profile. Tucker, A., Ma, J., Sparavalo, S., et al.[2023]

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 open-modified Bankart procedure shows good long-term results for shoulder stability, with only 10% of patients experiencing redislocations after an average follow-up of 21 years.

Despite its effectiveness in reducing dislocations, the procedure does not prevent the development of osteoarthritis, as over half of the patients showed radiological signs of mild osteoarthritis in the operated shoulder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The open-modified Bankart procedure: long-term follow-up 'a 16-26-year follow-up study'. Berendes, T., Mathijssen, N., Verburg, H., et al.[2021]

In a study of 89 patients who underwent open Bankart surgery for recurrent anterior shoulder dislocation with glenoid bone defects and Hill-Sachs lesions, the surgery resulted in a low recurrence rate of 16.8% over an average follow-up of 7 years.

Patients reported excellent shoulder function post-surgery, with a mean visual analogue scale (VAS) pain score of 0.4 and high scores on activity and shoulder function assessments, indicating that open Bankart surgery is an effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of Open Bankart Surgery for Recurrent Anterior Shoulder Dislocation with Glenoid Bone Defect and Concomitant Hill-Sachs Lesion. Amroodi, MN., Jafari, D., Kousari, AA.[2022]

The combined arthroscopic Bankart repair and remplissage procedure (BRR) shows a low rate of recurrent dislocation at 3.4% among 220 patients followed for an average of 26 months, indicating its efficacy in managing recurrent shoulder instability.

Patients experienced no significant loss in shoulder motion after the procedure, along with favorable functional outcomes and high satisfaction rates, suggesting that BRR is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined arthroscopic Bankart repair and remplissage for recurrent shoulder instability. Leroux, T., Bhatti, A., Khoshbin, A., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2059775421001024

Systematic review Arthroscopic anatomic glenoid ... Glenoid bone loss can be associated with recurrent anterior shoulder instability and can lead to unsuccessful stabilisation procedures if not addressed.

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

3. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00394-X/fulltext

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. ...

4. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(24)00494-8/fulltext

Arthroscopic Anatomic Glenoid Reconstruction With ... Bone loss of either/both the glenoid and humeral head increases the risk of redislocation even after initial isolated soft-tissue stabilization.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2059775422000669

Arthroscopic anatomic glenoid reconstruction has a lower ... AAGR using DTA has demonstrated excellent clinical outcomes with low recurrence rates and a reassuring safety profile, making it a phenomenal surgical option ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5971393/

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.

7. jisakos.com jisakos.com/article/S2059-7754(25)00389-X/fulltext

Arthroscopic Anatomic Glenoid Reconstruction ... Conclusion: AAGR demonstrates an excellent safety profile comparable to Bankart repair with no associated incidence of recurrent dislocation. AAGR graft ...

8. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00008-8/fulltext

Revision of Failed Arthroscopic Anatomic Glenoid ... This article describes revision of AAGR using screw fixation after failed primary AAGR with button fixation. We outline a stepwise approach to guide the ...