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

Smith & Nephew

Status: Terminated

Conditions: Traumatic Arthritis; Osteo Arthritis Shoulders; Rheumatoid Arthritis

Treatments: Device: Integra Titan Modular Shoulder System 2.5

Study type: Observational

Funder types: Industry

Identifiers

NCT03250767

T-TSS-003

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

58 participants in 1 patient group

Integra Titan Modular Shoulder System 2.5

Treatment:

Device: Integra Titan Modular Shoulder System 2.5