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

Sponsor

Zimmer Biomet (Industry)

Overall Status

Terminated

CT.gov ID

NCT01480453

Collaborator

(none)

Enrollment

Locations

95.9

Actual Duration (Months)

22.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Ununited Humeral Head Fracture Irreducible 3- and 4-part Proximal Humeral Fractures Avascular Necrosis	Device: Trabecular Metal Humeral Stem

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 Design

Study Type:

Observational

Actual Enrollment :

67 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Retrospective and Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Humeral Stem

Actual Study Start Date :

Jan 2, 2011

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Trabecular Metal Humeral Stem Patients requiring primary, total or hemi shoulder arthroplasty who receive the Trabecular Metal Humeral Stem.	Device: Trabecular Metal Humeral Stem Trabecular Metal Humeral Stem used in primary, total or hemi shoulder arthroplasty Other Names: TM Humeral Stem TM Humeral

Arm

Intervention/Treatment

Trabecular Metal Humeral Stem

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

Device: Trabecular Metal Humeral Stem

Trabecular Metal Humeral Stem used in primary, total or hemi shoulder arthroplasty

Other Names:

TM Humeral Stem

TM Humeral

Outcome Measures

Primary Outcome Measures

Survivorship [10 Years]
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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