An observational study in Arthritis, Arthritis, Degenerative and Rheumatoid Arthritis, sponsored by Smith & Nephew, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by Smith & Nephew, Inc. · Observational
A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.
Observational, multi-center, post-market study to provide data on the performance and safety of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5 years ago. Available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. Prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's enrollment of 50 is below the median of 151 across 202 observational studies indexed under Arthritis.
Browse Arthritis studies →Smith & Nephew, Inc. is the lead sponsor of 134 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Integra TITAN™ Total Shoulder System Generation 1.0
Device: Integra TITAN™ Total Shoulder Generation 1.0
Total Shoulder Arthroplasty or Hemiarthroplasty
Implant survival at 2 years
Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
Time frame: 2 years
Implant survival .
Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
Time frame: 5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline
Relative change of Range of Motion (ROM) compared to baseline
Time frame: 2, 5, and 10 years
Radiographic assessment
Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency
Time frame: 2, 5, and 10 years
Relative change in Quality Of Life (EQ-5D) compared to baseline
Relative change in Quality Of Life (EQ-5D) compared to baseline
Time frame: 2, 5, and 10 years
Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
Time frame: 2, 5, and 10 years
Relative change of PENN Pain and Function Score (PENN) compared to baseline
Relative change of PENN Pain and Function Score (PENN) compared to baseline
Time frame: 2, 5, and 10 years
Relative change in Quality Of Life (SF-12V1) compared to baseline
Relative change in Quality Of Life (SF-12V1) compared to baseline
Time frame: 2, 5, and 10 years
This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.