Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Reverse Should System Used in Primary or Revision Reverse Total Shoulder Arthroplasty

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Post-traumatic Arthritis; Revision Total Shoulder Arthroplasty; Ununited Humeral Head Fracture; Irreducible 3-and 4-part Proximal Humeral Fractures; Gross Rotator Cuff Deficiency
• Intervention / Treatment: Device: Trabecular Metal Reverse Shoulder System

Detailed Description

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total 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 Reverse Shoulder System.

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 Reverse Shoulder System.

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 Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Blackburn, Lancashire, United Kingdom, BB2 3HH
      • Royal Blackburn Hospital
• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Orthopaedic & Sports Medicine
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • The Rothman Institute
  • 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

• 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, irreduciable 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff dificiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision) 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 or revision unilateral or bilateral reverse total 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, gross rotator cuff deficiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision);
• 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 willing 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 Institutional Review Board (IRB)/Ethical Review Board (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 Reverse Shoulder System; Patients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System	Device: Trabecular Metal Reverse Shoulder System; Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty; Other Names: TM Reverse Shoulder System; TM Reverse System; TM Reverse

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 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Rheumatoid Arthritis; Avascular necrosis; Post-traumatic arthritis; Ununited humeral head fracture; Reverse Total Shoulder Arthroplasty (TSA); Reverse TSA; Irreducible 3-and 4-part proximal humeral fractures; Gross rotator cuff deficiency; Failed total shoulder arthroplasty; Revision total shoulder arthroplasty
• 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: CMU2010-28E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes