Arthroscopic Bankart repair procedure for Shoulder Dislocation

Phase-Based Estimates
1
Effectiveness
1
Safety
Rhode Island Hospital- University Orthopedics, Providence, RI
Shoulder Dislocation+3 More
Arthroscopic Bankart repair procedure - Procedure
Eligibility
< 65
All Sexes
Eligible conditions
Shoulder Dislocation

Study Summary

Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial

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Eligible Conditions

  • Shoulder Dislocation
  • Luxatio Erecta
  • Shoulder Anterior Dislocation
  • Joint Dislocations
  • Glenohumeral Dislocation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Arthroscopic Bankart repair procedure will improve 3 primary outcomes and 21 secondary outcomes in patients with Shoulder Dislocation. Measurement will happen over the course of 24 months after surgery.

12 months after surgery
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Clinical Measures after Surgical Stabilization - Neurovascular status
Clinical Measures after Surgical Stabilization - Pain
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Clinical Measures after Surgical Stabilization - Wound Status
24 months after randomization
Brief Resilience Scale
Brophy Shoulder Activity Level
Patient Acceptable Symptom State (PASS)
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
Recurrent Instability / Re-injury
Western Ontario Shoulder Instability Index (WOSI)
24 months after surgery
Functional Comorbidity Index
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
Single Assessment Numerical Evaluation (SANE)
Tampa Scale for Kinesiophobia-11 (TSK-11)
6 months after surgery
Isometric Muscle Strength of the Shoulder
Passive Range of Motion of the Shoulder
Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test
Performance on Functional Tests of the Upper Extremity - Push-ups
Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test
Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test
Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw
Month 24
Time to Return to Pre-Injury Level of Activity

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation

This trial requires 400 total participants across 3 different treatment groups

This trial involves 3 different treatments. Arthroscopic Bankart Repair Procedure is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitationArthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.
Latarjet/rehabilitationLatarjet surgical procedure and post-operative rehabilitation.
Open Bankart/rehabilitationOpen Bankart surgery and post-operative rehabilitation.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: monthly starting at 3 months after randomization and continuing to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly monthly starting at 3 months after randomization and continuing to 24 months for reporting.

Who is running the study

Principal Investigator
A. P.
Prof. Adam Popchak, Research Assistant Professor
University of Pittsburgh

Closest Location

Rhode Island Hospital- University Orthopedics - Providence, RI

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Shoulder Dislocation or one of the other 3 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The standard of care CT scan showed that the patient had a subcritical bone loss between 10-20% less than the width of her glenoid. show original
Civilians and military personnel ages 17 to 50
Traumatic anterior shoulder dislocation

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is shoulder dislocation?

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For shoulder dislocations in general, and proximal dislocation specifically, the incidence was not as high as 10%. Patients with shoulder dislocations should receive immediate and thorough clinical evaluation in order to minimize the risk of long-term disability. Appropriate referral to shoulder surgery is essential for patients with proximal dislocation.

Unverified Answer

What are common treatments for shoulder dislocation?

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Treatment for shoulder dislocation can sometimes be conservative. In other cases, an operation may be required. Patients should be kept immobilized while awaiting the results of diagnostic imaging after a shoulder dislocation. Surgery is usually not needed to treat shoulder dislocation, but a shoulder immobilizer or a sling may be kept in place until the dislocation resolves. Surgeons often recommend surgery when the shoulder is dislocated more than 2-3 times in the previous year and to prevent a fracture of the reverse shoulder. If surgery is performed, it is often followed by physiotherapy to help recover the full range of motion of the shoulder within about 6 to 8 weeks.

Unverified Answer

How many people get shoulder dislocation a year in the United States?

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A total of approximately 15,000 shoulder dislocations occur each year in the United States. Furthermore, the incidence of shoulder dislocations is higher in women and in the young.

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What are the signs of shoulder dislocation?

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An increase in pain, swelling or deformity is commonly (70%) reported following shoulder dislocation. Analgesic use alone tends to relieve only an estimated 20 to 30% of pain. Surgical options are available to relieve this pain in most cases. However, these are fraught with a high rate of complications and long hospitalizations.

Unverified Answer

What causes shoulder dislocation?

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There are multiple causes that contribute to shoulder injuries in adolescents and the mechanism of shoulder dislocation in young patients is different from that of adults. Adolescent patients may be at higher risk for shoulder injuries through specific risk factors.

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Can shoulder dislocation be cured?

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Despite some optimistic results from experimental studies, including earlier studies of the effects of anteroposterior shoulder dislocation on the shoulder joint, it appears that the shoulder cannot be cured. Although functional outcomes, including the ability to return to activities of daily living, can be improved with shoulder dislocation, they are not sufficiently excellent to equate with complete reconstruction of the anatomical integrity of the shoulder joint.

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How serious can shoulder dislocation be?

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There is no significant difference in the incidence of redisplaced shoulder dislocation amongst the age groups. The shoulder dislocation with open and closed reduction in the same day is also not statistically significant. So, patients with shoulder dislocation should not be treated as urgent and be sent to the emergency room to reduce the dislocation overnight. To prevent recurrent dislocations in the future, patients can be instructed on the correct posture and movements to reduce a possible dislocation. We can also educate patients on the proper shoulder positioning and movements to minimize the chances of inducing a dislocational episode. Patients can also be instructed to not roll the arm over on the back.

Unverified Answer

What are the latest developments in arthroscopic bankart repair procedure for therapeutic use?

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There is a growing body of evidence that suggests that the arthroscopic Bankart arthroplasty with the screw-in anchors has better postoperative results even when compared with the conventional Bankart arthroplasty method. There is no evidence that a minimally invasive technique may yield increased morbidity or mortality compared with the conventional Bankart arthroplasty. The main disadvantage of the screw-in anchor technique is the increased necessity for postoperative rehabilitation.

Unverified Answer

Has arthroscopic bankart repair procedure proven to be more effective than a placebo?

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Arthroscopic Bankart repair, with autoloike structures preservation and tendon remodeling, was found to be more effective than a placebo. This procedure did not appear to increase the risk on postoperative shoulder pain.

Unverified Answer

Have there been any new discoveries for treating shoulder dislocation?

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For shoulder dislocation which is refractory to conservative interventions, conservative therapy should be combined with surgical intervention. However, the long-term effect of surgical intervention is worse than conservative therapy for shoulder dislocation. If patients have no other medical problems, nonoperative treatment should be taken into consideration.

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What are the common side effects of arthroscopic bankart repair procedure?

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The common side effects of arthroscopic bankart repair include shoulder discomfort, ecchymosis, transient hypotension, transient brachial plexus palsy, shoulder pain, numbness, etc. Some authors propose that they are tolerable. Nevertheless, all of the above-mentioned side effects may be improved through better surgical technique, such as increased-size anchors placement.

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Does shoulder dislocation run in families?

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Findings from a recent study shows that the risk of a first shoulder dislocation among relatives of shoulder dislocation patients is relatively high. Although the risk of shoulder dislocation in relatives is lower than observed that of the index patient, this result supports the concept that shoulder dislocations are familial at least in part.

Unverified Answer
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