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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 November 2023
• Main ID: NCT03250767
• Date of registration: 11/08/2017
• Prospective Registration: No
• Primary sponsor: Smith & Nephew, Inc.
• Public title: Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
• Scientific 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
• Date of first enrolment: August 1, 2017
• Target sample size: 58
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03250767
• Study type: Observational

Countries of recruitment

United States

Key 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. 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)

4. Ununited humeral head fractures

5. Avascular necrosis of the humeral head

6. Rotator cuff arthropathy

7. Deformity and/or limited motion

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Traumatic Arthritis

Rheumatoid Arthritis

Osteo Arthritis Shoulders

Intervention(s)

Device: Integra Titan Modular Shoulder System 2.5

Primary Outcome(s)

Implant Survivorship [Time Frame: 2 years]

Secondary Outcome(s)

Implant Survivorship [Time Frame: 1,5 and 10 years]

Relative change of Constant-Murley Score (CMS) 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]

Relative change of Range of Motion (ROM) 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]

Secondary ID(s)

T-TSS-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors