Status:
TERMINATED
Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.
Detailed Description
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty. This will be done by analysis of st...
Eligibility Criteria
Inclusion
- Patient is \>18 years of age;
- Patient is skeletally mature;
- Patient qualifies for primary unilateral or bilateral total or hemi shoulder arthroplasty based on physical exam and medical history including the following: Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis
- Patient is willing and able to provide written informed consent;
- Patient is willing and able to cooperate in the required post-operative therapy;
- Patient is will and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
- Patient has participated in the Informed Consent process and has signed the IRB/ERB approved informed consent;
Exclusion
- The patient is a prisoner;
- The patient is mentally incompetent or unable to understand what participation in the study entails;
- The patient is a known alcohol or drug abuser;
- The patient is anticipated to be non-compliant;
- The patient has one of the following compromising the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
- The patient has a local/systemic infection;
- The patient is known to be pregnant;
- The patient has marked bone loss;
- The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
- The patient is unwilling or unable to give consent or to comply with the follow-up program.
Key Trial Info
Start Date :
January 2 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01480453
Start Date
January 2 2011
End Date
December 31 2018
Last Update
March 26 2019
Active Locations (3)
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1
Norton Orthopaedic Specialists
Louisville, Kentucky, United States, 40241
2
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
3
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107