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Fixed Inclination Humeral Cut

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922763
Recruitment Status : Unknown
Verified April 2019 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Shoulder Osteoarthritis Procedure: Anatomical cut Procedure: Cutting guide Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : February 2, 2020
Estimated Study Completion Date : May 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922763


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03922763    
Other Study ID Numbers: 2019Laz
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases