Osteo Arthritis ShouldersNCT03250767
Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
An observational study of Osteo Arthritis Shoulders and Traumatic Arthritis, run by Smith & Nephew, Inc. at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Shoulders, Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Integra Titan Modular Shoulder System 2.5
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Aug 2017to 10 Mar 2023
- 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: Patients with shoulder arthritis requiring primary shoulder joint replacement
Who may be able to join
- For total shoulder arthroplasty, subjects must meet a, b, or c below:
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
- For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
Show all 12Show fewer
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
- Ununited humeral head fractures
- Avascular necrosis of the humeral head
- Rotator cuff arthropathy
- Deformity and/or limited motion
Who cannot join
- Absent, irreparable or nonfunctional rotator cuff or other essential muscles.
- Have an active local or systemic infection.
- Have inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
- Have poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
- Have a muscular, neurologic, or vascular deficiencies that compromise the affected extremity.
- Have a known sensitivity or allergic reaction to one or more of the implanted materials.
- Have a condition that may impair proper wound healing.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111
John Hopkins University
Columbia, Maryland, 21044
Westphal Orthopaedics
Lancaster, Pennsylvania, 17601
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Rothman Institute
Philadelphia, Pennsylvania, 19107
Mississipi Bone and Joint Clinic
Starkville, Mississippi, 39759
The Research Foundation for The State University of New York (SUNY)
Syracuse, New York, 13210
About this study
Official title: A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
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.
- Being tested
- Integra Titan Modular Shoulder System 2.5
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integra Titan Modular Shoulder System 2.5Device
Primary Shoulder Joint Replacement
| Study group | Role | What they receive |
|---|---|---|
| Integra Titan Modular Shoulder System 2.5 | Not described Receives: Device: Integra Titan Modular Shoulder System 2.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Implant survivorship defined as absence of device removal or revision
Measured: 2 years
Secondary outcomes (7)
Implant Survivorship
Implant survivorship defined as absence of device removal or revision
Measured: 1,5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline
Relative change of ROM compared to baseline
Measured: up to 10 years
Relative change of Constant-Murley Score (CMS) compared to baseline
Relative change of CMS compared to baseline
Measured: up to 10 years
Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline
Relative change of ASES compared to baseline
Measured: up to 10 years
Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline
Relative change of SANE compared to baseline
Measured: up to 10 years
Relative change of Simple Shoulder Test (SST) compared to baseline
Relative change of SST compared to baseline
Measured: up to 10 years
Relative change of Pain compared to baseline
Relative change of Visual Analogue Scale (VAS) Pain compared to baseline
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Aug 2017
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Why it stopped: 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 Osteo Arthritis ShouldersStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250767
- Sponsor's protocol ID
- T-TSS-003
- Status last verified
- Nov 2023
- First submitted
- 11 Aug 2017
- Last updated
- 9 Nov 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
- ClinicalTrials.gov ID
- NCT03250767
- Acronym / sponsor ID
- T-TSS-003
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision not due to adverse events, complications, or device issues.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 16 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, 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integra Titan Modular Shoulder System 2.5 | – | Device: Integra Titan Modular Shoulder System 2.5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with shoulder arthritis requiring primary shoulder joint replacement
Key inclusion criteria (12 listed)
- For total shoulder arthroplasty, subjects must meet a, b, or c below:
- For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:
Key exclusion criteria (7 listed)
- Absent, irreparable or nonfunctional rotator cuff or other essential muscles.
- Have an active local or systemic infection.
- Have inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
- Have poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
- Have a muscular, neurologic, or vascular deficiencies that compromise the affected extremity.
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 Modular Shoulder System 2.5Primary Shoulder Joint Replacement | Device | Integra Titan Modular Shoulder System 2.5 |
Primary outcome
Implant Survivorship
Time frame: 2 years
Implant survivorship defined as absence of device removal or revision
7 secondary outcomes
Implant Survivorship
Time frame: 1,5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline
Time frame: up to 10 years
Relative change of Constant-Murley Score (CMS) compared to baseline
Time frame: up to 10 years
Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline
Time frame: up to 10 years
Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline
Time frame: up to 10 years
Relative change of Simple Shoulder Test (SST) compared to baseline
Time frame: up to 10 years
Relative change of Pain compared to baseline
Time frame: up to 10 years
Results and safety
The study was stopped early (reason given: 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 9 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Shoulders and Traumatic Arthritis, run by Smith & Nephew, Inc. at 7 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 12 inclusion and 7 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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: 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 Survivorship (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 9 Nov 2023.