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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Zimmer, Inc.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01480453
First received: November 23, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Humeral Stem

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Survivorship [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
    Based on removal or intended removal of the device and determined using the Kaplan-Meier method.


Secondary Outcome Measures:
  • Pain and Functional Performance [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
    Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480453

Contacts
Contact: Kelly Francher, BA, CCRC, CCRA 574-371-8316 kelly.francher@zimmer.com
Contact: Jeff Schram, BS, MS 574-372-4666 jeff.schram@zimmer.com

Locations
United States, California
University of California, San Francisco Withdrawn
San Francisco, California, United States, 94143
United States, Kentucky
Norton Orthopaedic Specialists Recruiting
Louisville, Kentucky, United States, 40241
Contact: Barbara Patterson    502-629-3219    barbara.patterson@nortonhealthcare.org   
Principal Investigator: Ryan Krupp, MD         
United States, Pennsylvania
The Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Thema Nicholson       thema.nicholson@rothmaninstitute.com   
Principal Investigator: Joseph Abboud, MD         
Canada, British Columbia
University of British Columbia Hospital, Vancouver Withdrawn
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01480453     History of Changes
Other Study ID Numbers: CMU2010-29E
Study First Received: November 23, 2011
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
Osteoarthritis
Rheumatoid arthritis
Post-traumatic arthritis
Ununited humeral head fracture
Irreducible 3- and 4-part proximal humeral fractures
Avascular necrosis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Fractures, Bone
Humeral Fractures
Necrosis
Osteonecrosis
Osteoarthritis
Shoulder Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Arm Injuries
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on July 09, 2014