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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01480453
• Other study ID #: CMU2010-29E
• Status: Terminated
• Start date: January 2, 2011
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Fractures, Bone
• Humeral Fractures
• Irreducible 3- and 4-part Proximal Humeral Fractures
• Necrosis
• Osteoarthritis
• Osteonecrosis
• Post-traumatic Arthritis
• Rheumatoid Arthritis
• Shoulder Fractures
• Ununited Humeral Head Fracture

Intervention

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

Locations

Country	Name	City	State
United States	Norton Orthopaedic Specialists	Louisville	Kentucky
United States	The Rothman Institute	Philadelphia	Pennsylvania
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	Based on removal or intended removal of the device and determined using the Kaplan-Meier method.	10 Years
Secondary	Pain and Functional Performance	Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)	10 Years