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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to investigate arthroscopic treatments of recurrent anterior shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft will provide better functional outcomes and decreased risk of recurrent dislocation/subluxation. This will be a single center, double blinded, randomized controlled trial performed in Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation, and range of motion. A minimum of 200 patients will be enrolled in the study as determined by sample size calculation. Routine radiographs as well as a pre-operative CT with 3D reconstruction and MRI are obtained for all patients. The patients will then undergo a clinical examination and complete a variety of functional and quality of life surveys. Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both groups will follow a standardized rehabilitation protocol. The patient will follow-up with the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a physiotherapist who is blinded to the patients' treatment group. The patient will also complete the questionnaires at each of these follow-up appointments. Complications, and subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.

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 data supports the effectiveness of the treatment Anatomic Glenoid Reconstruction, AGR, Anatomic Glenoid Reconstruction Procedure, Arthroscopic Bankart Repair for shoulder dislocation?

The study on Bankart reconstruction showed that 94% of patients regained normal shoulder stability after the procedure, indicating its effectiveness in treating recurrent shoulder dislocation. Additionally, the use of suture anchors in the procedure simplified the surgery without specific complications. ^{1 2 3 4 5}

Is shoulder surgery for dislocation generally safe?

Research shows that shoulder surgeries like Arthroscopic Anatomic Glenoid Reconstruction and Arthroscopic Bankart Repair have similar safety profiles, with complications such as infection and stiffness being rare. Using bone grafts from the iliac crest is considered safe, though donor site issues can occur. ^{1 6 7 8 9}

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

The Anatomic Glenoid Reconstruction (AGR) treatment is unique because it involves reconstructing the glenoid (the socket part of the shoulder joint) to restore stability, which is particularly beneficial for patients with bone defects. This approach differs from the standard Bankart repair, which primarily focuses on soft tissue repair without addressing bone loss. ^{1 3 4 8 10}

Research Team

Ivan H Wong, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Repair of Bankart lesions with a suture anchor in recurrent dislocation of the shoulder. [2019]

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

Combined arthroscopic Bankart repair and remplissage for recurrent shoulder instability. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

The open-modified Bankart procedure: long-term follow-up 'a 16-26-year follow-up study'. [2021]

4. Singapore pubmed.ncbi.nlm.nih.gov

Modified Bankart procedure for recurrent anterior shoulder dislocation. [2016]

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

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

6. England 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. [2023]

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

Arthroscopic Glenoid Bone Augmentation Using Iliac Crest Autograft Is Safe and Effective for Anterior Shoulder Instability With Bone Loss. [2022]

8. 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]

9. Germany pubmed.ncbi.nlm.nih.gov

Massive graft resorption after iliac crest allograft reconstruction for glenoid bone loss in recurrent anterior shoulder instability. [2020]

10. Iran pubmed.ncbi.nlm.nih.gov

Results of Open Bankart Surgery for Recurrent Anterior Shoulder Dislocation with Glenoid Bone Defect and Concomitant Hill-Sachs Lesion. [2022]