Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty

Terminated

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Ununited Humeral Head Fracture; Irreducible 3- and 4-part Proximal Humeral Fractures; Avascular Necrosis
• Interventions: Device: Trabecular Metal Humeral Stem

• Registration Number: NCT01480453
• Lead Sponsor: Zimmer Biomet

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 standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Humeral Stem.

Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular Metal Humeral Stem.

Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the SF-12 as well as AEs and radiographic parameters by analysis of x-rays.

Study Timeline

• Study Start: 2011-01-02
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-28
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trabecular Metal Humeral Stem	Trabecular Metal Humeral Stem	Patients requiring primary, total or hemi shoulder arthroplasty who receive the Trabecular Metal Humeral Stem.

Primary Outcome Measures

Name	Time	Method
Survivorship	10 Years	Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Pain and Functional Performance	10 Years	Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)

Trial Locations

Locations (3)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Norton Orthopaedic Specialists; 🇺🇸 Louisville, Kentucky, United States

The Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States