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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Each year within Canada and the US, more than 30,000 children and adolescents will have an injury to their shoulder resulting in a shoulder dislocation. Although the current practice is to manage this initial dislocation without surgery, the vast majority of these children and adolescents will, unfortunately continue to have instability episodes of their shoulder. Recurrent instability can cause damage to the bones and cartilage that form the shoulder resulting in potentially more difficult surgical stabilization, and possibly long-term sequela. To that effect, there is increasing interest to consider early surgical stabilization in this population. This pilot randomized controlled trial (RCT) will evaluate the feasibility of conducting a larger RCT assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations (recurrent instability), pain, and shoulder function among adolescents (aged 12-18 years) with first-time shoulder dislocations. These patients will be followed for one year.

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 arthroscopic stabilization for shoulder dislocation generally safe for humans?

Arthroscopic stabilization of the shoulder is a minimally invasive technique that is widely used and generally considered safe, with low rates of complications and recurrence in both short-term and long-term follow-up studies. ^{1 2 3 4 5}

How is arthroscopic stabilization different from other treatments for shoulder dislocation?

Arthroscopic stabilization is a minimally invasive treatment for shoulder dislocation that involves using small incisions and a camera to repair the shoulder joint, offering benefits like shorter hospital stays and less trauma to soft tissues compared to open surgery. It is particularly useful for patients with recurrent dislocations and labral detachment, although it may have a higher recurrence rate than open procedures in the long term. ^{1 2 5 6 7}

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

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

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

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

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]

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 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]

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]

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 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]

Citations

1. Czech Republic pubmed.ncbi.nlm.nih.gov

[Arthroscopic stabilization of the shoulder]. [2006]

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

Arthroscopic procedures for the treatment of anterior shoulder instability: local experiences. [2016]

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

Arthroscopic repair of acute traumatic anterior shoulder dislocation in young athletes. [2022]

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

Factors Related to Patient Dissatisfaction Versus Objective Failure After Arthroscopic Shoulder Stabilization for Instability. [2021]

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

Long-term results after arthroscopic shoulder stabilization using suture anchors: an 8- to 10-year follow-up. [2022]

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

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

7. Poland pubmed.ncbi.nlm.nih.gov

Arthroscopic management of anterior instability of the shoulder. [2016]