Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- For total shoulder arthroplasty, subjects must meet a, b, or c below: 1.

Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. 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. 3. 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: 1.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03250767
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Smith & Nephew, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteo Arthritis Shoulders, Traumatic Arthritis, Rheumatoid Arthritis

Arms & Interventions

Arms

: Integra Titan Modular Shoulder System 2.5

Interventions

Device: - Integra Titan Modular Shoulder System 2.5

Primary Shoulder Joint Replacement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Active, not recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0111

Site Contact

[email protected]

(+1) 737-932-3602

John Hopkins University, Columbia, Maryland

Status

Recruiting