Shoulder DislocationNCT05160909
Evaluation of Surgical Positioning in Arthroscopic Shoulder Stabilization
An observational study of Shoulder Dislocation, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to prospectively determine whether intra-operative factors, complications and post-operative outcomes differ between beach chair and lateral decubitus surgical positioning for patients receiving arthroscopic shoulder stabilization (anterior or posterior) due to shoulder instability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Beach Chair Position and Lateral Decubitus Position
- Type of treatment
- Surgery or procedure
- How many people
- 556 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 6 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who undergo arthroscopic labral repair due to shoulder instability, with or without concomitant debridement.
Who may be able to join
- -Any patient undergoing arthroscopic labral repair due to shoulder instability, with or without concomitant debridement.
Who cannot join
- Revision stabilization surgery
- No previous Bankart repairs, labral repairs, capsulorrhaphy, or Latarjet
- Multidirectional shoulder instability
- Concomitant rotator cuff repair, biceps tenodesis/tenotomy, HAGL repair
- Isolated SLAP repair/labral repair in association with mechanism other than -instability (eg: overhead athletes) open procedures for instability
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Effects of Surgical Positioning on Arthroscopic Shoulder Stabilization: A Prospective Comparison
The purpose of this study is to prospectively determine whether intra-operative factors, complications and post-operative outcomes differ between beach chair and lateral decubitus surgical positioning for patients receiving arthroscopic shoulder stabilization (anterior or posterior) due to shoulder instability.
- Conditions
- Shoulder Dislocation
- Being tested
- Beach Chair Position, Lateral Decubitus Position
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beach Chair PositionProcedure or surgery
Patients positioned in beach chair during arthroscopic shoulder stabilization
Lateral Decubitus PositionProcedure or surgery
Patients positioned in lateral decubitus position during arthroscopic shoulder stabilization
| Study group | Role | What they receive |
|---|---|---|
| Beach Chair | Patient positioned in beach chair position during arthroscopic shoulder stabilization Receives: Procedure: Beach Chair Position | |
| Lateral decubitus | Patient positioned in lateral decubitus position during arthroscopic shoulder stabilization Receives: Procedure: Lateral Decubitus Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder instability
Participants will be asked by their surgeon at routine follow up visits if they have encountered any episodes of shoulder instability (shoulder dislocations)
Measured: 2 years
Secondary outcomes (3)
Postoperative patient satisfaction
Participant satisfaction will be measured using the American Shoulder and Elbow Surgeons score (ASES)
Measured: 2 years
Postoperative patient satisfaction
Participant satisfaction will be measured using the Single Assessment Numerical Evaluation survey (SANE)
Measured: 2 years
Postoperative patient satisfaction
Participant satisfaction will be measured using the Western Ontario Shoulder Instability (WOSI) index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start6 Dec 2021
- Primary completion6 Dec 2023 (estimated)
- Study completion6 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160909
- Sponsor's protocol ID
- MBis21E.593
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Surgical Positioning on Arthroscopic Shoulder Stabilization: A Prospective Comparison
- ClinicalTrials.gov ID
- NCT05160909
- Acronym / sponsor ID
- MBis21E.593
- Conditions
- Shoulder Dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Dec 2023 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively determine whether intra-operative factors, complications and post-operative outcomes differ between beach chair and lateral decubitus surgical positioning for patients receiving arthroscopic shoulder stabilization (anterior or posterior) due to shoulder instability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beach Chair | – | Procedure: Beach Chair PositionPatient positioned in beach chair position during arthroscopic shoulder stabilization |
| Lateral decubitus | – | Procedure: Lateral Decubitus PositionPatient positioned in lateral decubitus position during arthroscopic shoulder stabilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo arthroscopic labral repair due to shoulder instability, with or without concomitant debridement.
Key inclusion criteria (1 listed)
- -Any patient undergoing arthroscopic labral repair due to shoulder instability, with or without concomitant debridement.
Key exclusion criteria (5 listed)
- Revision stabilization surgery
- No previous Bankart repairs, labral repairs, capsulorrhaphy, or Latarjet
- Multidirectional shoulder instability
- Concomitant rotator cuff repair, biceps tenodesis/tenotomy, HAGL repair
- Isolated SLAP repair/labral repair in association with mechanism other than -instability (eg: overhead athletes) open procedures for instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beach Chair PositionPatients positioned in beach chair during arthroscopic shoulder stabilization | Procedure or surgery | Beach Chair |
| Lateral Decubitus PositionPatients positioned in lateral decubitus position during arthroscopic shoulder stabilization | Procedure or surgery | Lateral decubitus |
Primary outcome
Shoulder instability
Time frame: 2 years
Participants will be asked by their surgeon at routine follow up visits if they have encountered any episodes of shoulder instability (shoulder dislocations)
3 secondary outcomes
Postoperative patient satisfaction
Time frame: 2 years
Postoperative patient satisfaction
Time frame: 2 years
Postoperative patient satisfaction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Dislocation, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder instability (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.