Fixed Inclination Humeral Cut
April 19, 2019 updated by: Rothman Institute Orthopaedics
Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients 18 years or older
- primary glenohumeral osteoarthritis
- intact rotator cuff
- primary anatomic shoulder arthroplasty
Exclusion Criteria:
- revision arthroplasty
- reverse shoulder arthroplasty candidates
- cognitive or behavioral problems which would preclude informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Anatomically-matched cut
|
Surgeon-derived cut based on patient's anatomy
|
|
Active Comparator: Cutting guide
|
Angle cut at 132.5 degrees based on cutting guide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radriographic measurements
Time Frame: x-rays taken day of surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2019
Primary Completion (Anticipated)
February 2, 2020
Study Completion (Anticipated)
May 2, 2020
Study Registration Dates
First Submitted
April 17, 2019
First Submitted That Met QC Criteria
April 19, 2019
First Posted (Actual)
April 22, 2019
Study Record Updates
Last Update Posted (Actual)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 19, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019Laz
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.