Clinical trial NCT02204228: TITAN™ Reverse Shoulder System
Official title: A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Osteoarthritis of the Shoulder
Keywords: osteoarthritis
rheumatoid arthritis
post traumatic arthritis
avascular necrosis
severe fractures
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 151
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require reverse shoulder replacement due to the inclusions below.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival (lack of implant component removal or revision)
timeFrame: 2 Year
Secondary outcomes:
measure: Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES)
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM)
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Efficacy assessed by comparing clinical results after surgery as measured with Constant score.
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS).
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation)
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Efficacy assessed by comparing clinical results after surgery as measured with Radiographs
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Lack of unanticipated device related serious adverse events.
timeFrame: 2 Year/5 Year/ 7Year/ 10 Year
measure: Survival (lack of implant component removal or revision)
timeFrame: 5 Year/7 Year/10 Year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Columbia
country: United States
facility: Johns Hopkins University
state: Maryland
city: Starkville
country: United States
facility: Mississipi Bone and Joint Clinic
state: Mississippi
city: Glen Ridge
country: United States
facility: Active Orthopedics
state: New Jersey
city: Lancaster
country: United States
facility: Westphal Orthopaedics
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Paris
country: France
facility: Clinique Bizet
city: Manacor
country: Spain
facility: Hospital de Manacor - Llevant
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
affiliation: Smith & Nephew, Inc.
name: Karlie Morgan
role: STUDY_DIRECTOR
References: