Back to resultsFixed Inclination Humeral Cut
Primary Purpose
Shoulder Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anatomical cut
Cutting guide
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Rothman Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anatomically-matched cut
Cutting guide
Arm Description
Outcomes
Primary Outcome Measures
Radriographic measurements
x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement
Secondary Outcome Measures
Full Information
NCT ID
NCT03922763
First Posted
April 17, 2019
Last Updated
April 19, 2019
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03922763
Brief Title
Fixed Inclination Humeral Cut
Official Title
Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
February 2, 2020 (Anticipated)
Study Completion Date
May 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anatomically-matched cut
Arm Type
Active Comparator
Arm Title
Cutting guide
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Anatomical cut
Intervention Description
Surgeon-derived cut based on patient's anatomy
Intervention Type
Procedure
Intervention Name(s)
Cutting guide
Intervention Description
Angle cut at 132.5 degrees based on cutting guide
Primary Outcome Measure Information:
Title
Radriographic measurements
Description
x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement
Time Frame
x-rays taken day of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fixed Inclination Humeral Cut
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