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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01480440
Recruitment Status : Active, not recruiting
First Posted : November 28, 2011
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date November 23, 2011
First Posted Date November 28, 2011
Last Update Posted Date September 8, 2021
Actual Study Start Date January 2011
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2011)
Survivorship [ Time Frame: 10 Years ]
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 25, 2011)
Pain and Functional Performance [ Time Frame: 10 Years ]
Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
Official Title Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Reverse Should System Used in Primary or Revision Reverse Total Shoulder Arthroplasty
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Post-traumatic Arthritis
  • Ununited Humeral Head Fracture
  • Irreducible 3-and 4-part Proximal Humeral Fractures
  • Avascular Necrosis
  • Gross Rotator Cuff Deficiency
  • Revision Total Shoulder Arthroplasty
Intervention 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
Study Groups/Cohorts Trabecular Metal Reverse Shoulder System
Patients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System
Intervention: Device: Trabecular Metal Reverse Shoulder System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 25, 2011)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number NCT01480440
Other Study ID Numbers CMU2010-28E
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date September 2021