Arthroscopic Stabilization vs Rehabilitation for Shoulder Dislocation
(PROMPTCohort Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether early surgery or rehabilitation better serves teens who have dislocated their shoulder for the first time. It seeks to determine which approach reduces repeat dislocations and improves shoulder function and pain. The study compares arthroscopic stabilization (a type of minimally invasive surgery) to a rehabilitation plan involving immobilization and physical therapy. Teens who experienced a first-time shoulder dislocation in the past five months and have been diagnosed with specific shoulder instability are ideal candidates for this trial. Researchers will track participants for a year to assess outcomes. As an unphased trial, this study allows participants to contribute to valuable research that could shape future treatment options for shoulder dislocations.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that arthroscopic stabilization for shoulder dislocation is generally well-tolerated. One study found that 98% of patients had stable shoulders three years post-surgery, indicating its effectiveness in preventing further dislocations. Another study reported a 91% reduction in dislocation rates following this surgery. Patients without bone loss in the shoulder also face a low risk of dislocating again after the procedure.
However, athletes, particularly those in sports involving frequent overhead movements, might experience more frequent shoulder instability and may find it harder to return to their sport. Despite this, the overall rate of shoulder instability recurrence after surgery was about 17.3%, which remains relatively low. For most patients, the surgery results in satisfying outcomes and a good range of motion.12345Why are researchers excited about this trial?
Researchers are excited about the trial comparing arthroscopic stabilization to rehabilitation for shoulder dislocation because it explores two distinct approaches to managing this common injury. Arthroscopic stabilization is unique because it directly repairs the soft tissue tears in the shoulder using suture anchors, potentially offering a more permanent fix by addressing the root cause of instability. This surgical method could offer more reliable long-term results compared to traditional non-surgical rehabilitation, which mainly focuses on immobilization and physical therapy to restore function. By comparing these methods, researchers hope to determine which approach leads to better outcomes in terms of shoulder stability and return to activity.
What evidence suggests that this trial's treatments could be effective for shoulder dislocation?
Research has shown that arthroscopic stabilization, a procedure participants in this trial may receive, can significantly reduce the risk of shoulder redislocation. One study found that this surgery lowered the risk of redislocation by 91% compared to no surgery. Another study showed that after the procedure, only about 8.5% to 9.8% of patients experienced shoulder instability again. These findings indicate that arthroscopic stabilization effectively maintains shoulder stability. For teenagers experiencing their first shoulder dislocation, this surgery might prevent future issues and reduce the need for additional surgeries. Meanwhile, another group in this trial will follow a rehabilitation protocol, which includes immobilization and physical therapy, to evaluate its effectiveness in managing shoulder dislocation.12367
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either arthroscopic stabilization or rehabilitation with immobilization followed by physical therapy
Rehabilitation
Participants in both groups follow a rehabilitation protocol, with a goal of returning to activities or sports
Follow-up
Participants are monitored for safety and effectiveness, including rates of recurrent dislocation and pain assessment
What Are the Treatments Tested in This Trial?
Interventions
- Arthroscopic stabilization
- Rehabilitation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Citations
Arthroscopic stabilization surgery for first-time anterior ...
Ultimately, this review found a statistically significant 91% reduction in shoulder redislocation rates when comparing ABR after a single dislocation to ...
Outcomes of arthroscopic stabilization for recurrent ...
The rate of post-stabilization instability was 9.8% in first-time dislocators, 9.1% in recurrent dislocators, and 8.5% in a mixed cohort. A ...
A Decision-Analytic Markov Model-Based Analysis
We found that ABR significantly reduces the risk for recurrent shoulder dislocations, with recurrence rates of 55% and 16% for nonoperative ...
4.
sportssurgerychicago.com
sportssurgerychicago.com/attachments/2016/07/arthroscopic-opentabilization-techniques-restore-equivalent-stability-shoulder-setting-anterior-glenohumeral-instability.pdfDo Arthroscopic and Open Stabilization Techniques Restore
Methods: In this study we evaluate available scientific support for the ability of both arthroscopic and open soft-tissue stabilization techniques to restore ...
Long Term Outcomes of Arthroscopic Shoulder Instability ...
They report however a recurrence rate of 21%, (although only 14% proceeded to revision surgery) and a 28% rate of moderate or severe dislocation arthropathy.
6.
moonshoulder.com
moonshoulder.com/wp-content/uploads/2020/04/Clinical-outcomes-after-anterior-stabilization-in-overhead-athletes.pdfClinical-outcomes-after-anterior-stabilization-in-overhead- ...
Overhead ath- letes may experience a higher rate of recurrent instability and difficulty returning to sport postoperatively with limited previous literature to ...
Mid- to Long-Term Outcomes of Arthroscopic Shoulder ...
The rate of return to sport at pre-injury level was 65.2% (range, 40–82.6%) across four studies. The overall rate of recurrent instability was 17.3%, with ...
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