ArthritisNCT03245320
Clinical Evaluation of the TITAN™ Total Shoulder System
An observational study of Arthritis and Arthritis, Degenerative, run by Smith & Nephew, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Arthritis, Degenerative, Rheumatoid Arthritis
- What is being tested?
- Integra TITAN™ Total Shoulder Generation 1.0
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2017to 23 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
Who may be able to join
- Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
- The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
- Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
Who cannot join
- Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OrthoIndy
Indianapolis, Indiana, 46278
The Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
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.
Read the detailed description
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.
- Conditions
- Arthritis, Arthritis, Degenerative, Rheumatoid Arthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture
- Being tested
- Integra TITAN™ Total Shoulder Generation 1.0
- Medical subject headings
- Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Fractures, Bone, Osteonecrosis, Joint Instability, Shoulder Dislocation, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integra TITAN™ Total Shoulder Generation 1.0Device
Total Shoulder Arthroplasty or Hemiarthroplasty
| Study group | Role | What they receive |
|---|---|---|
| TITAN™ Total Shoulder System Generation 1.0 | Integra TITAN™ Total Shoulder System Generation 1.0 Receives: Device: Integra TITAN™ Total Shoulder Generation 1.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (7)
Implant survival .
Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
Measured: 5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline
Relative change of Range of Motion (ROM) compared to baseline
Measured: 2, 5, and 10 years
Radiographic assessment
Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2, 5, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start20 Mar 2017
- Primary completion22 Mar 2022
- Study completion23 Jun 2022
Why it stopped: Terminated by the Sponsor. Decision not due to adverse events, complications, or device issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Tummon, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245320
- Sponsor's protocol ID
- T-TSS-002
- Status last verified
- Dec 2023
- First submitted
- 3 May 2017
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
- ClinicalTrials.gov ID
- NCT03245320
- Acronym / sponsor ID
- T-TSS-002
- Conditions
- Arthritis, Arthritis, Degenerative, Rheumatoid Arthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated by the Sponsor. Decision not due to adverse events, complications, or device issues.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TITAN™ Total Shoulder System Generation 1.0 | – | Device: Integra TITAN™ Total Shoulder Generation 1.0Integra TITAN™ Total Shoulder System Generation 1.0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
Key inclusion criteria (3 listed)
- Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
- The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
- Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
Key exclusion criteria (2 listed)
- Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integra TITAN™ Total Shoulder Generation 1.0Total Shoulder Arthroplasty or Hemiarthroplasty | Device | TITAN™ Total Shoulder System Generation 1.0 |
Primary outcome
Implant survival at 2 years
Time frame: 2 years
Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
7 secondary outcomes
Implant survival .
Time frame: 5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline
Time frame: 2, 5, and 10 years
Radiographic assessment
Time frame: 2, 5, and 10 years
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
Time frame: 2, 5, and 10 years
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
Time frame: 2, 5, and 10 years
Results and safety
The study was stopped early (reason given: Terminated by the Sponsor. Decision not due to adverse events, complications, or device issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Tummon study director
Integra LifeSciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Arthritis, Degenerative, run by Smith & Nephew, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated by the Sponsor. Decision not due to adverse events, complications, or device issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.