Evaluation of Surgical Positioning in Arthroscopic Shoulder Stabilization

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05160909
• Collaborator: (none)
• Enrollment: 556
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 23.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Procedure: Beach Chair Position; Procedure: Lateral Decubitus Position

Study Design

• Study Type: Observational
• Anticipated Enrollment: 556 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effects of Surgical Positioning on Arthroscopic Shoulder Stabilization: A Prospective Comparison
• Actual Study Start Date: Dec 6, 2021
• Anticipated Primary Completion Date: Dec 6, 2023
• Anticipated Study Completion Date: Dec 6, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Shoulder instability [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)

Secondary Outcome Measures

1. Postoperative patient satisfaction [2 years]

   Participant satisfaction will be measured using the American Shoulder and Elbow Surgeons score (ASES)

2. Postoperative patient satisfaction [2 years]

   Participant satisfaction will be measured using the Single Assessment Numerical Evaluation survey (SANE)

3. Postoperative patient satisfaction [2 years]

   Participant satisfaction will be measured using the Western Ontario Shoulder Instability (WOSI) index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT05160909
• Other Study ID Numbers: MBis21E.593
• First Posted: Dec 16, 2021
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shoulder Dislocation

Study Results

No Results Posted as of Dec 16, 2021