NCT05160909

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

December 6, 2021

Last Update Submit

December 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Postoperative patient satisfaction

    2 years

  • Postoperative patient satisfaction

    2 years

  • Postoperative patient satisfaction

    2 years

Study Arms (2)

Beach Chair

Patient positioned in beach chair position during arthroscopic shoulder stabilization

Procedure: Beach Chair Position

Lateral decubitus

Patient positioned in lateral decubitus position during arthroscopic shoulder stabilization

Procedure: Lateral Decubitus Position

Interventions

Patients positioned in beach chair during arthroscopic shoulder stabilization

Beach Chair

Patients positioned in lateral decubitus position during arthroscopic shoulder stabilization

Lateral decubitus

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 16, 2021

Study Start

December 6, 2021

Primary Completion

December 6, 2023

Study Completion

December 6, 2023

Last Updated

December 16, 2021

Record last verified: 2021-12

Locations