TITAN™ Reverse Shoulder System

NCT02204228 | Terminated FDA Device

• 1 other identifier: CP-0960-001
• Study Type: observational
• Target: 151
• Locations: 4 countries
• Sites: 10

Brief Summary

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.

Conditions

Osteoarthritis of the Shoulder

Keywords

osteoarthritis; rheumatoid arthritis; post traumatic arthritis; avascular necrosis; severe fractures

Outcome Measures

Primary Outcomes (1)

• Survival (lack of implant component removal or revision)

  Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.

  2 Year

Secondary Outcomes (9)

• Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)

  2 Year/5 Year/ 7Year/ 10 Year

• Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score

  2 Year/5 Year/ 7Year/ 10 Year

• Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)

  2 Year/5 Year/ 7Year/ 10 Year

• Efficacy assessed by comparing clinical results after surgery as measured with Constant score.

  2 Year/5 Year/ 7Year/ 10 Year

• Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS).

  2 Year/5 Year/ 7Year/ 10 Year

Study Arms (1)

TITAN™ Reverse Shoulder System (TRS)

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

Device: TITAN™ Reverse Shoulder System (TRS)

Interventions

TITAN™ Reverse Shoulder System (TRS) DEVICE

All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).

TITAN™ Reverse Shoulder System (TRS)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require reverse shoulder replacement due to the inclusions below.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (10)

University of Florida

Gainesville, Florida, 32607, United States

Location

Johns Hopkins University

Columbia, Maryland, 21044, United States

Location

Mississipi Bone and Joint Clinic

Starkville, Mississippi, 39759, United States

Location

Active Orthopedics

Glen Ridge, New Jersey, 07028, United States

Location

Westphal Orthopaedics

Lancaster, Pennsylvania, 17601, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Clinique Bizet

Paris, France

Location

Hospital de Manacor - Llevant

Manacor, 07500, Spain

Location

Barts Health NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Karlie Morgan

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 30, 2014
• Study Start: September 1, 2014
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (7); GB (1); FR (1); ES (1)