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

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01480440

Collaborator

(none)

200

Enrollment

Locations

191

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Survivorship [10 Years]
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

Secondary Outcome Measures

Pain and Functional Performance [10 Years]
Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143
2	Norton Orthopaedic & Sports Medicine	Louisville	Kentucky	United States	40241
3	The Rothman Institute	Egg Harbor Township	New Jersey	United States	08234
4	The Rothman Institute	Philadelphia	Pennsylvania	United States	19107
5	Royal Blackburn Hospital	Blackburn	Lancashire	United Kingdom	BB2 3HH