A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.
Study Type
OBSERVATIONAL
Enrollment
58
Primary Shoulder Joint Replacement
University of Alabama at Birmingham
Birmingham, Alabama, United States
John Hopkins University
Columbia, Maryland, United States
Mississipi Bone and Joint Clinic
Starkville, Mississippi, United States
The Research Foundation for The State University of New York (SUNY)
Syracuse, New York, United States
Implant Survivorship
Implant survivorship defined as absence of device removal or revision
Time frame: 2 years
Implant Survivorship
Implant survivorship defined as absence of device removal or revision
Time frame: 1,5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline
Relative change of ROM compared to baseline
Time frame: up to 10 years
Relative change of Constant-Murley Score (CMS) compared to baseline
Relative change of CMS compared to baseline
Time frame: up to 10 years
Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline
Relative change of ASES compared to baseline
Time frame: up to 10 years
Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline
Relative change of SANE compared to baseline
Time frame: up to 10 years
Relative change of Simple Shoulder Test (SST) compared to baseline
Relative change of SST compared to baseline
Time frame: up to 10 years
Relative change of Pain compared to baseline
Relative change of Visual Analogue Scale (VAS) Pain compared to baseline
Time frame: up to 10 years
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Westphal Orthopaedics
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Rothman Institute
Philadelphia, Pennsylvania, United States