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NCT05160909 Clinical Trial

Evaluation of Surgical Positioning in Arthroscopic Shoulder Stabilization

Shoulder Dislocation Clinical Trial

Official title:
The Effects of Surgical Positioning on Arthroscopic Shoulder Stabilization: A Prospective Comparison

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05160909
Other study ID # MBis21E.593
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 6, 2021
Est. completion date December 6, 2023

Study information
Verified date December 2021
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 556
Est. completion date December 6, 2023
Est. primary completion date December 6, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Beach Chair Position
Patients positioned in beach chair during arthroscopic shoulder stabilization
• Lateral Decubitus Position
Patients positioned in lateral decubitus position during arthroscopic shoulder stabilization

Locations
Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

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