Surgical Treatments for Shoulder Instability

Overseen By Matt Miller, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Uncontrolled diabetes, Pregnancy, Cancer, others

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

Compensation: Varies

Number of Visits: 7

Duration: Surgical procedure with immediate post-operative care

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the investigators will conduct this pilot trial comparing arthroscopic Bankart repair with arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates and functional outcomes over a 24-month period. The feasibility objectives are: (1) to evaluate the investigators ability to recruit patients across multiple sites and (2) to assess study protocol adherence and ability to follow patients to 24 months. Clinical objectives for the pilot trial are exploratory only. The investigators wish to gather means and standard deviations for clinical outcomes to power their future definitive trial. The objectives of the definitive trial will include a comparison of patient-reported outcomes at the two-year post-operative time point, differences in recurrence rates, complication rates, functional shoulder assessments, and return to work/sport.

Do I need to stop my current medications for the trial?

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

Is the surgical treatment for shoulder instability safe?

The surgical treatments for shoulder instability, including Arthroscopic Bankart Repair and Anatomic Glenoid Reconstruction, generally have a similar safety profile with low rates of complications like infection or nerve issues. Most patients regain normal shoulder stability, and specific techniques like using suture anchors have not shown additional complications. ^{1 2 3 4 5}

How does the Anatomic Glenoid Reconstruction and Bankart Repair treatment differ from other treatments for shoulder instability?

The Anatomic Glenoid Reconstruction and Bankart Repair treatment is unique because it involves reattaching the labrum (a ring of cartilage) to the shoulder socket using suture anchors, which can be done arthroscopically (through small incisions) or through an open procedure. This approach helps restore shoulder stability and avoids complications associated with larger incisions, offering improved cosmetic results and outcomes similar to traditional open techniques. ^{2 6 7 8 9}

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

Research shows that surgical procedures like the Bankart repair, which is part of Anatomic Glenoid Reconstruction, are effective for treating shoulder instability. Studies found that most patients regained shoulder stability and returned to their previous activity levels, with a high percentage experiencing satisfactory outcomes and no recurrent dislocations. ^{2 5 9 10 11}

Who Is on the Research Team?

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for individuals with recurrent shoulder dislocations who have specific bone loss visible on imaging. It's not suitable for those with uncontrolled diabetes, pregnancy, severe illness, massive rotator cuff tears, certain levels of bone loss, posterior instability, shoulder paralysis, cancer, generalized laxity or previous surgery on the affected shoulder.

Inclusion Criteria

Presence of glenoid and/or humerus bone loss on imaging (X-ray, CT, or MRI)

My shoulder has dislocated at the front twice or more.

Exclusion Criteria

Multidirectional instability

I have cancer.

Posterior instability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either arthroscopic Bankart repair or arthroscopic anatomic glenoid reconstruction (AAGR) for anterior shoulder instability

Surgical procedure with immediate post-operative care

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety, recurrence of dislocation, and functional outcomes

24 months

Regular follow-up visits at 6 months, 1 year, and 2 years

Long-term Follow-up

Participants continue to be monitored for long-term outcomes and recurrence rates

Additional follow-up beyond 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Anatomic Glenoid Reconstruction
• Bankart Repair

Trial Overview The study compares two surgical methods: arthroscopic Bankart repair and anatomic glenoid reconstruction to see which is better at preventing dislocations over a 24-month period. This pilot trial will test how well the study can be done across multiple sites and if patients stick to the protocol.

How Is the Trial Designed?

Group I: Anatomic Glenoid Reconstruction Experimental Treatment 1 Intervention

The surgical technique was the lateral decubitus all-arthroscopic anatomic glenoid reconstruction procedure for treatment of anterior shoulder instability as described by Wong et al. (2015). The procedure is done in a semi-lateral decubitus position that assists with optimal graft placement on the native glenoid. The investigators utilize the cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA). The surgical technique is identical to that of arthroscopic Bankart repair with one additional step. Prior to insertion of anchors, one additional medal portal is created for insertion of the bone graft. The distal tibia allograft is prepared; the cannulated guide is attached and advanced through the rotator interval and secured with two cannulated screws. Finally, the Bankart repair is performed above the graft. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

Group II: Bankart Repair Active Control 1 Intervention

Arthroscopic Bankart repair procedures will be performed according to each individual surgeon's usual technique. Procedures will be performed with the patient in the lateral or beach-chair position. Repairs for associated or conjoined superior labral anterior-to-posterior (SLAP) tears will be documented and performed at the surgeon's discretion. Labral detachments will be repaired with the use of suture-anchor fixation and arthroscopic tying techniques. Either two or three suture anchors will be used. Capsular redundancy will be addressed with arthroscopic suture plication at the surgeon's discretion. Surgeons will mobilize the capsulolabral tissue as deemed necessary. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

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+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study of 32 patients who underwent modified Bankart reconstruction using a suture anchor, there were no complications reported, and 93% achieved excellent or good results after an average follow-up of 42 months.

The technique allowed 26 patients to return to their pre-surgery activity levels without experiencing recurrent dislocation, highlighting its efficacy, although proper anchor placement is crucial to avoid technical failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the suture anchor in open Bankart reconstruction. A follow-up report. Levine, WN., Richmond, JC., Donaldson, WR.[2017]

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]

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 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 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]

The study presents a new technique for Arthroscopic Bankart repair that utilizes a single anterior working portal instead of the traditional two portals, potentially simplifying the procedure.

This method aims to achieve comparable outcomes to the established two-portal technique, making it a reproducible option for restoring the labrum to the glenoid rim.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Working Portal Technique for Knotless Arthroscopic Bankart Repair. Ng, DZ., Lau, BPH., Tan, BHM., et al.[2020]

The study found that the recurrence rate of shoulder instability after arthroscopic Bankart repair can vary significantly, ranging from 3.4% to 35% over a 10-year follow-up period, highlighting the importance of understanding individual risk factors.

Key risk factors for recurrence include being under 22 years old, male gender, having multiple preoperative dislocations, and using fewer than three anchors during surgery, which can help guide surgical decisions and patient counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for recurrence after Bankart repair a systematic review. Randelli, P., Ragone, V., Carminati, S., et al.[2022]

Arthroscopic Bankart repair using suture anchors is now the preferred method for treating anterior shoulder instability in patients who haven't responded to conservative treatments, moving away from traditional open surgery.

Recent technical advancements and a better understanding of factors contributing to shoulder instability have led to improved outcomes for arthroscopic repairs, making them comparable to those achieved with open surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Bankart repair: Have we finally reached a gold standard? Castagna, A., Garofalo, R., Conti, M., et al.[2022]

In a study of 28 patients with traumatic anterior shoulder instability, arthroscopic Bankart repair successfully restored shoulder stability without any recurrence of instability in 25 patients post-surgery.

The procedure not only improved joint stability but also resulted in significantly higher scores on the MISS questionnaire, indicating better patient-reported outcomes and fewer complications compared to traditional open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Arthroscopic Bankart repair]. Zarzycki, W.[2014]

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]

Citations

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

Use of the suture anchor in open Bankart reconstruction. A follow-up report. [2017]

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

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

3. Denmark pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

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

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. Netherlands pubmed.ncbi.nlm.nih.gov

Single Working Portal Technique for Knotless Arthroscopic Bankart Repair. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Risk factors for recurrence after Bankart repair a systematic review. [2022]

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

Arthroscopic Bankart repair: Have we finally reached a gold standard? [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

[Arthroscopic Bankart repair]. [2014]

11. 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]