Fixed Inclination Humeral Cut

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Shoulder Osteoarthritis

Treatments: Procedure: Cutting guide; Procedure: Anatomical cut

Study type: Interventional

Funder types: Other

Identifiers

NCT03922763

2019Laz

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Anatomically-matched cut

Active Comparator group

Treatment:

Procedure: Anatomical cut

Cutting guide

Active Comparator group

Treatment:

Procedure: Cutting guide