Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Avascular Necrosis of the Head of Humerus
  • Osteo Arthritis Shoulders
  • Rotator Cuff Tear
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: single arm, historically controlled, multi-centerMasking: None (Open Label)Masking Description: no masking due to being a single arm studyPrimary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

Description

The clinical study will enroll patient who require a reverse total shoulder arthroplasty as a result of osteoarthritis, post-traumatic arthritis, avascular necrosis and have a massive and non-repairable rotator cuff tear and a functional deltoid muscle. If patients meet the eligibility criteria, eva...

The clinical study will enroll patient who require a reverse total shoulder arthroplasty as a result of osteoarthritis, post-traumatic arthritis, avascular necrosis and have a massive and non-repairable rotator cuff tear and a functional deltoid muscle. If patients meet the eligibility criteria, evaluations and x-rays will be completed pre-operatively and post-operatively out to 24 months.

Tracking Information

NCT #
NCT03806842
Collaborators
Not Provided
Investigators
Study Director: Kathy Trier, PhD FX Shoulder USA, Inc.