Arthroscopic Stabilization vs Rehabilitation for Shoulder Dislocation

(PROMPT Trial)

Overseen By Nicole Simunovic, MSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Previous dislocation, Surgeries, Ligamentous laxity, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early surgery or physical therapy is more effective for teens with a first-time shoulder dislocation. It compares arthroscopic stabilization, a minimally invasive surgery, with rehabilitation involving a sling followed by physical therapy. The goal is to determine which method better prevents future shoulder dislocations, reduces pain, and improves shoulder function. Teens aged 12-18 who have recently experienced their first shoulder dislocation may be suitable candidates. As an unphased trial, this study provides teens the opportunity to contribute to important research that could enhance treatment options for shoulder dislocations.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that arthroscopic stabilization surgery is generally safe and effective for treating shoulder dislocations. It often results in good outcomes, with a low risk of the shoulder dislocating again. Serious complications after the surgery are rare, with only about 3.8% of patients requiring another surgery within a year.

Rehabilitation is also safe, with a low risk of recurrence. For instance, one study found that only 2% of participants experienced another dislocation after rehab. These findings suggest that both treatment options are well-tolerated and carry a low risk of serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing arthroscopic stabilization and rehabilitation for shoulder dislocation because each approach offers unique benefits. Arthroscopic stabilization involves a minimally invasive surgery that directly repairs the tissues in the shoulder to prevent future dislocations, potentially offering a more permanent solution compared to traditional methods like immobilization and physical therapy alone. On the other hand, the rehabilitation approach focuses on strengthening the shoulder through a structured regimen of immobilization followed by physical therapy, which is less invasive and avoids surgical risks. Understanding which method provides better long-term stability and recovery could significantly enhance treatment outcomes for patients with shoulder dislocations.

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

This trial will compare arthroscopic stabilization surgery with rehabilitation, which includes a period of immobilization followed by physical therapy, for treating shoulder dislocation. Research has shown that arthroscopic stabilization surgery often results in fewer repeat dislocations and better shoulder stability over time. Studies indicate that individuals undergoing this surgery are less likely to experience another dislocation compared to those who do not. In contrast, a common non-surgical approach involves immobilization and physical therapy, but surgery generally proves more effective at preventing future shoulder instability. For teenagers and young adults, surgery is often considered more effective at preventing future shoulder problems. Overall, while both surgical and non-surgical methods aim to improve shoulder health, arthroscopic stabilization may offer more reliable long-term results in preventing repeat dislocations. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adolescents aged 12-18 with a first-time traumatic shoulder dislocation confirmed by radiography, needing reduction or showing anterior apprehension. They must have MRI evidence of soft tissue damage and be able to understand English. Consent is required from the individual or parents for minors.

Inclusion Criteria

Patients who have the ability to speak, understand, and read English

I am between 12 and 18 years old.

My shoulder was dislocated forward and needed medical help to fix.

Exclusion Criteria

My shoulder injury is larger than 15% of my upper arm bone's width.

Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up

My shoulder has dislocated before or feels unstable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either arthroscopic stabilization or rehabilitation with immobilization followed by physical therapy

6 months

Multiple visits for surgery and rehabilitation sessions

Follow-up

Participants are monitored for recurrent shoulder dislocations, pain, and shoulder function

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Arthroscopic Stabilization
• Rehabilitation including a period of immobilization followed by physical therapy

Trial Overview This trial tests early arthroscopic stabilization surgery against rehabilitation (immobilization followed by physical therapy) in adolescents after their first shoulder dislocation. It aims to see which method better prevents repeat dislocations, reduces pain, and improves shoulder function over one year.

How Is the Trial Designed?

Group I: Arthroscopic stabilization Active Control 1 Intervention

Patients will have an initial evaluation with a diagnostic shoulder arthroscopy and examination under anesthesia will be performed to confirm the degree of anterior instability and assess range of motion of the affected shoulder. Diagnostic arthroscopy will commence with the use of 3 standard shoulder portals (posterior viewing and two anterior working portals for suture passing), and a detailed arthroscopic examination will be performed. Once the soft tissue tear (including the labrum, and capsule labrum ligaments) is identified, it will be mobilized using a rasp or elevator and a burr will then be used to create a surface for a bleeding bone bed. Capsulolabral repair will then commence with the labrum fixed to the glenoid using suture anchors (the Bankart repair). Following surgery, subjects in this group will follow the same rehabilitation protocol as the comparison group.

Group II: Rehabilitation including a period of immobilization followed by physical therapy Active Control 1 Intervention

Subjects in this group will use an internal-rotation shoulder immobilizer, using a standard sling for 6 weeks from the day of enrollment. Subjects will be advised to maintain range of motion (ROM) in the elbow and wrist during this period of time. The immobilizer can be removed for passive pendulum exercises and elbow ROM during the period of immobilization up to 4 times per day. Formal physiotherapy commences at 4 weeks post-enrollment, with a goal of return to activities or sport at 6-months post-enrollment.

Arthroscopic Stabilization is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Arthroscopic Shoulder Stabilization for:

• Shoulder instability
• Recurrent shoulder dislocations
• Traumatic shoulder dislocations

Approved in Canada as Arthroscopic Shoulder Stabilization for:

• Shoulder instability
• Recurrent shoulder dislocations
• Traumatic shoulder dislocations

Approved in European Union as Arthroscopic Shoulder Stabilization for:

• Shoulder instability
• Recurrent shoulder dislocations
• Traumatic shoulder dislocations

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

In a retrospective study of 18 patients who underwent arthroscopic stabilization for recurrent anterior shoulder dislocation, the procedure resulted in good overall outcomes, with 14 out of 16 patients reporting minimal or no pain and a mean Constant score of 80.

There were no cases of re-dislocation or major complications, indicating that arthroscopic stabilization is a safe and effective treatment option for recurrent shoulder instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic procedures for the treatment of anterior shoulder instability: local experiences. Choi, ST., Tse, PY.[2016]

In a study of 91 patients with recurrent anterior shoulder instability, arthroscopic stabilization using suture anchors significantly improved shoulder function, with the mean Rowe score increasing from 37.1 preoperatively to 87.4 postoperatively.

The majority of patients (71.4%) reported excellent functional outcomes after surgery, indicating that this technique is effective for preventing further dislocations and restoring shoulder stability, although 5 patients experienced recurrence of instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic management of anterior instability of the shoulder. Ozorak, M., Kokavec, M., Svec, A.[2016]

Arthroscopic stabilization of the unstable glenohumeral joint is a promising alternative to open surgical procedures, particularly for patients with recurrent dislocations and labral detachment, but it currently shows a higher rate of recurrence compared to the open Bankart procedure.

While arthroscopic techniques offer benefits like shorter hospital stays and less soft tissue trauma, more long-term studies are needed to fully evaluate their efficacy and to compare them directly with open techniques to determine the best approach for shoulder stabilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances and perspectives on arthroscopic stabilization of the shoulder. Cash, JD.[2021]

In a long-term follow-up study of 67 patients who underwent arthroscopic stabilization for shoulder dislocations, 35% experienced at least one redislocation after 8 to 10 years, indicating a notable recurrence rate despite initial stabilization.

Patients who did not experience redislocations reported significantly better shoulder function, highlighting the importance of preventing redislocations for optimal recovery; additionally, using fewer than 3 suture anchors and the presence of a Hill-Sachs defect were associated with a higher risk of redislocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after arthroscopic shoulder stabilization using suture anchors: an 8- to 10-year follow-up. van der Linde, JA., van Kampen, DA., Terwee, CB., et al.[2022]

In a study of 46 young patients with acute anterior shoulder dislocation, those who underwent arthroscopic repair had a 96% success rate with excellent outcomes, while only 5.5% of those treated nonoperatively achieved similar results.

The nonoperative group experienced a high redislocation rate of 94.5%, compared to just 4% in the surgical group, highlighting the effectiveness of surgical intervention in preventing future dislocations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic repair of acute traumatic anterior shoulder dislocation in young athletes. Larrain, MV., Botto, GJ., Montenegro, HJ., et al.[2022]

In a study of 195 patients who underwent arthroscopic stabilization for shoulder instability, 7.7% experienced objective surgical failure, defined as recurrent instability requiring revision surgery.

Subjective patient dissatisfaction was linked to the width of the Hill-Sachs lesion and the number of instability events, while a concomitant SLAP repair was associated with greater satisfaction, highlighting that factors influencing patient satisfaction differ from those affecting surgical success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Related to Patient Dissatisfaction Versus Objective Failure After Arthroscopic Shoulder Stabilization for Instability. Park, I., Kang, JS., Jo, YG., et al.[2021]

Arthroscopic stabilization of the shoulder is an effective surgical technique for treating traumatic anterior glenohumeral dislocation, with 75.4% of patients achieving excellent results after the procedure.

The technique significantly reduces the risk of recurrent dislocation compared to conventional treatment, with only 3.9% of patients experiencing repeat dislocations, making it a reliable option for patients with shoulder instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Arthroscopic stabilization of the shoulder]. Sadovský, P., Musil, D., Stehlík, J.[2006]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1058274624001551

Arthroscopic stabilization surgery for first-time anterior ... Arthroscopic stabilization surgery for FTASDs leads to lower rates of redislocations, cumulative instability, and subsequent stabilization surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7275285/

Arthroscopic stabilisation for shoulder instability - PMC This review will focus on the indications, pre-operative considerations, surgical techniques and outcomes of arthroscopic stabilisation.

3. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(09)00518-0/fulltext

Arthroscopic Stabilization for First-Time Versus Recurrent ... The purpose of this study was to systematically review the evidence on the outcomes of arthroscopic repair for anterior shoulder instability in first-time ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05532150

Conservative Versus Operative - First Time Shoulder ... This study aims to compare the incidence of recurrent shoulder instability and patient reported outcomes of patients with primary anterior shoulder dislocations ...

5. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(21)00264-4/fulltext

Single-Portal Arthroscopic Posterior Shoulder Stabilization Our technique involves 1 less portal to reduce invasiveness, lower the risk of nerve damage, and decrease the operative time and postoperative pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6537070/

Arthroscopic Treatment of First-Time Shoulder Dislocations ... The procedure was an effective and safe treatment for this population. It provided good functional outcomes, a low recurrence rate, and a low rate of ...

7. mdpi.com mdpi.com/2077-0383/12/17/5730

Mid- to Long-Term Outcomes of Arthroscopic Shoulder ... Athletes who underwent primary shoulder arthroscopy demonstrated favorable outcomes and a high rate of RTS at a minimum follow-up of 5 years.

8. bmj.com bmj.com/content/378/bmj-2021-069901

Serious adverse event rates and reoperation after ... The likelihood of reoperation at one year after arthroscopic shoulder surgery was 3.8% overall (95% confidence interval 3.8% to 3.9%). Further ...

9. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/145056

The Role of Arthroscopy As Minimal Invasive for Shoulder ... Shoulder arthroscopy has several benefits over open surgery, such as less comorbidity, faster recovery, and social and economic benefits.