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History of Changes for Study: NCT03922763
Fixed Inclination Humeral Cut
Latest version (submitted April 19, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 19, 2019 None (earliest Version on record)
Comparison Format:

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Study NCT03922763
Submitted Date:  April 19, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2019Laz
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2019
Overall Status: Unknown status [Previously: Enrolling by invitation]
Study Start: February 2, 2019
Primary Completion: February 2, 2020 [Anticipated]
Study Completion: May 2, 2020 [Anticipated]
First Submitted: April 17, 2019
First Submitted that
Met QC Criteria:
April 19, 2019
First Posted: April 22, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
April 19, 2019
Last Update Posted: April 22, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Shoulder Osteoarthritis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Anatomically-matched cut Procedure: Anatomical cut
Surgeon-derived cut based on patient's anatomy
Active Comparator: Cutting guide Procedure: Cutting guide
Angle cut at 132.5 degrees based on cutting guide
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services