Fixed Inclination Humeral Cut
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Shoulder Osteoarthritis | Procedure: Anatomical cut Procedure: Cutting guide | Not Applicable |
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 |

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 |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |