TITAN™ Reverse Shoulder System

Osteoarthritis of the Shoulder Clinical Trial

Official title:

A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02204228
• Other study ID #: CP-0960-001
• Status: Suspended
• Start date: September 2014
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 151
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Shoulder

Intervention

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

Locations

Country	Name	City	State
France	Clinique Bizet	Paris
Spain	Hospital de Manacor - Llevant	Manacor
United Kingdom	Barts Health NHS Trust	London
United States	Johns Hopkins University	Columbia	Maryland
United States	University of Florida	Gainesville	Florida
United States	Active Orthopedics	Glen Ridge	New Jersey
United States	Westphal Orthopaedics	Lancaster	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Rothman Institute	Philadelphia	Pennsylvania
United States	Mississipi Bone and Joint Clinic	Starkville	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)	Relative change of ASES compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Secondary	Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score	Relative change of EQ-5D score compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Secondary	Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)	Relative change of ROM compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Secondary	Efficacy assessed by comparing clinical results after surgery as measured with Constant score.	Relative change of Constant score compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Secondary	Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS).	Relative change of Pain Visual Analog Scale (VAS) compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Secondary	Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation)	Relative change of SANE compared to baseline	2 Year/5 Year/ 7Year/ 10 Year
Secondary	Efficacy assessed by comparing clinical results after surgery as measured with Radiographs	Outcome after surgery will be evaluated using the Radiographs and comparison with pre-operative data.	2 Year/5 Year/ 7Year/ 10 Year
Secondary	Lack of unanticipated device related serious adverse events.	Any 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/5 Year/ 7Year/ 10 Year
Secondary	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.	5 Year/7 Year/10 Year