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NCT03922763 Clinical Trial

Fixed Inclination Humeral Cut

Shoulder Osteoarthritis Clinical Trial

Official title:
Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03922763
Other study ID # 2019Laz
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 2, 2019
Est. completion date May 2, 2020

Study information
Verified date April 2019
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date May 2, 2020
Est. primary completion date February 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. patients 18 years or older

2. primary glenohumeral osteoarthritis

3. intact rotator cuff

4. primary anatomic shoulder arthroplasty

Exclusion Criteria:

1. revision arthroplasty

2. reverse shoulder arthroplasty candidates

3. cognitive or behavioral problems which would preclude informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Anatomical cut
Surgeon-derived cut based on patient's anatomy
• Cutting guide
Angle cut at 132.5 degrees based on cutting guide

Locations
Country Name City State
United States Rothman 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 Radriographic measurements x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement x-rays taken day of surgery
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