Impact of Humeral Component Version on Outcomes Following RTSA

• Sponsor: William Beaumont Hospitals (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03111147
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 83.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear Arthropathy	Device: 0 degrees humeral component version; Device: 30 degrees humeral component retroversion	N/A

Detailed Description

Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
• Actual Study Start Date: May 12, 2017
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0 degrees humeral component version Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version	Device: 0 degrees humeral component version; RTSA with humeral component positioned in 0 degrees of version
Experimental: 30 degrees humeral component retroversion Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion	Device: 30 degrees humeral component retroversion; RTSA with humeral component positioned in 30 degrees of retroversion

Outcome Measures

Primary Outcome Measures

1. Postoperative ROM [2 years]

   External and internal range of motion measurements of the shoulder

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing primary reverse total shoulder arthroplasty

• Diagnosis of cuff tear arthropathy or primary OA with RCT

• Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam

• 18 years or older

Exclusion Criteria:

• Revision arthroplasty

• Diagnosis of rheumatoid arthritis, infection, acute trauma or instability

• Minors (under 18 years of age)

• Prior open shoulder surgery

• Concomitant latissimus dorsi transfer

• Patients not undergoing a standard of care physical therapy protocol

• Pregnant, patient-reported

• Cognitively impaired

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Health	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• William Beaumont Hospitals

Investigators

• Principal Investigator: J. Michael Wiater, MD, William Beaumont Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Wiater, ◾Vice Chairman Orthopedic Surgery◾Chief of Shoulder Surgery ◾Program Director, Fellowship in Shoulder and Elbow Surgery ◾Program Director, Orthopaedic Surgery Residency, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT03111147
• Other Study ID Numbers: 2017-057
• First Posted: Apr 12, 2017
• Last Update Posted: Dec 22, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Rotator Cuff Tear Arthropathy; Rotator Cuff Injuries

Study Results

No Results Posted as of Dec 22, 2021