Evaluation of Surgical Positioning in Arthroscopic Shoulder Stabilization

December 6, 2021 updated by: Rothman Institute Orthopaedics

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

556

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo arthroscopic labral repair due to shoulder instability, with or without concomitant debridement.

Description

Inclusion Criteria:

-Any patient undergoing arthroscopic labral repair due to shoulder instability, with or without concomitant debridement.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Beach Chair
Patient positioned in beach chair position during arthroscopic shoulder stabilization
Procedure: Beach Chair Position
Patients positioned in beach chair during arthroscopic shoulder stabilization
Lateral decubitus
Patient positioned in lateral decubitus position during arthroscopic shoulder stabilization
Procedure: Lateral Decubitus Position
Patients positioned in lateral decubitus position during arthroscopic shoulder stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative patient satisfaction
Time Frame: 2 years
Participant satisfaction will be measured using the American Shoulder and Elbow Surgeons score (ASES)
2 years
Postoperative patient satisfaction
Time Frame: 2 years
Participant satisfaction will be measured using the Single Assessment Numerical Evaluation survey (SANE)
2 years
Postoperative patient satisfaction
Time Frame: 2 years
Participant satisfaction will be measured using the Western Ontario Shoulder Instability (WOSI) index
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Anticipated)

December 6, 2023

Study Completion (Anticipated)

December 6, 2023

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBis21E.593

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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