TITAN™ Reverse Shoulder System

Smith & Nephew

Status: Terminated

Conditions: Osteoarthritis of the Shoulder

Treatments: Device: TITAN™ Reverse Shoulder System (TRS)

Study type: Observational

Funder types: Industry

Identifiers

NCT02204228

CP-0960-001

Details and patient eligibility

About

The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.

Enrollment: 151 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
• Subjects with a shoulder joint anatomically and structurally suited to receive the device
• Subjects at least 21 years of age and skeletally mature at the time of surgery
• Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)

Exclusion criteria

• Subjects without a functional deltoid muscle
• Subjects with active local or systemic infection
• Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
• Subjects with 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
• Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
• Subjects with known metal allergies
• Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
• Subjects who are prisoners
• Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods

Trial design

151 participants in 1 patient group

TITAN™ Reverse Shoulder System (TRS)

Description:

TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.

Treatment:

Device: TITAN™ Reverse Shoulder System (TRS)