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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Post-traumatic Arthritis; Ununited Humeral Head Fracture; Irreducible 3- and 4-part Proximal Humeral Fractures
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Orthopaedic Specialists
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • The Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Each investigator will screen from his/her patients who suffer from Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis who meet the inclusion/exclusion criteria stated in the protocol.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	Based on removal or intended removal of the device and determined using the Kaplan-Meier method.	10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2011
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: November 23, 2011
• First Submitted That Met QC Criteria: November 25, 2011
• First Posted (ESTIMATE): November 28, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Osteoarthritis; Rheumatoid arthritis; Avascular necrosis; Post-traumatic arthritis; Ununited humeral head fracture; Irreducible 3- and 4-part proximal humeral fractures
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Shoulder Injuries; Arm Injuries; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Necrosis; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: CMU2010-29E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED