Conservative Versus Operative - First Time Shoulder Dislocations

Study Purpose

There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations. This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- patients 12 and older.

- seen by the Columbia University Shoulder Elbow and Sports Medicine Service.

- first time anterior shoulder dislocation diagnosis.

Exclusion Criteria:

- humeral avulsion during arthroscopy.

- bony defect > 25% of glenoid surface.

- general anesthesia contraindication.

- previous shoulder surgery.

- inability or unwillingness to adhere to study participate.

- lost to follow up

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05532150
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Columbia University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Trofa, MD
Principal Investigator Affiliation	Assistant Professor of Orthopedic Surgery
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Shoulder Dislocation

Additional Details

While primary anterior shoulder dislocations had been previously treated conservatively, growing concerns amidst recurrent shoulder instability have fueled interest in managing these injuries with surgery to mitigate the risk of future instability events. While the significant literature investigating the rates of shoulder instability with initial operative management suggests improvement outcomes, there is limited level 1 evidence to support these implications. A randomized-controlled trial (RCT) of 21 primary anterior shoulder dislocations undergoing arthroscopic Bankart repair or rehabilitation ( 9 operative vs.#46;12 nonoperative; mean age: 22), found lower rates of recurrent shoulder instability (11% in operative vs.#46;72% in non-operative; p=0.004) and higher Single Assessment Numeric Evaluation (SANE) scores (88 in operative vs.#46;57 in non-operative; p<0.002) after 36 months of follow-up. Similarly, another RCT of 76 patients (37 operative vs.#46;39 non-operative; mean age: 22), found lower rates of recurrent shoulder instability (2.7% in operative vs.#46;53.8% in non-operative; p<0.01) and higher Oxford assessment scores (70% with either 'excellent' or 'good' scores in operative group vs.#46;26% with either 'excellent' or 'good' scores in non-operative group) after 10 years of follow-up. A RCT of 31 patients (16 operative vs.#46;15 non-operative; mean age: 22), found lower rates of recurrent instability ( 19% in operative vs.#46;60% in non-operative; p=0.02) but no significantly different Western Ontario Score Indices (WOSI) (86% in operative vs.#46; 75% in non-operative; p=0.17) at a follow up of 79 months. A RCT of 91 patients (44 operative vs.#46;47 non-operative; mean age: 22), found lower rates of recurrent instability (2.3% in operative vs.#46;19.1% in non-operative; p=0.01) and no significantly difference in WOSI (92.7% in operative vs.#46;91.5% in non-operative; p>0.05) at 2 years follow-up. A RCT of 40 patients (20 operative vs.#46;20 non-operative; mean age: 21), found lower rates of recurrent shoulder instability (10% in operative vs.#46;70% in non-operative; p=0.0001) and a higher WOSI (17.1 in operative vs.#46;11.5 in non-operative; p=0.035) at 2 years follow-up. The previous 5 RCT's represent the only level 1 evidence amidst a much larger proportion of lower-level evidence upon which much of the discussion of surgical vs.#46;non-operative management has been formulated. Additionally, only 2 RCT's conducted power analyses to determine if their sample size was adequate, and they did not demonstrate unanimous results with patient reported outcomes as described above. It is therefore critical to increase the amount of level 1 evidence on the topic of operative vs.#46;non-operative management of primary shoulder dislocations to better inform this debate. This study aims to compare the incidence of recurrent shoulder instability and patient reported outcomes of patients with primary anterior shoulder dislocations managed with surgery (arthroscopic Bankart repair) compared to non-operative management (standardized rehabilitation protocol, control group).

Arms & Interventions

Arms

Experimental: Operative group

The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.

Active Comparator: Non-operative group

The non-operative group will undergo physical therapy following a specific rehabilitation schedule.

Interventions

Procedure: - Arthroscopic Bankart repair

Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.

Procedure: - Physical therapy

Participants in this group will follow a specific physical therapy rehabilitation protocol

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Address

Columbia University Irving Medical Center

New York, New York, 10032

Site Contact

Christian A Pearsall, BS, BA

[email protected]

251-377-6058

Clinical Trial Finder