Clinical trial NCT03250767: Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
Official title: A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteo Arthritis Shoulders
Traumatic Arthritis
Rheumatoid Arthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with shoulder arthritis requiring primary shoulder joint replacement

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Implant Survivorship
timeFrame: 2 years
Secondary outcomes:
measure: Implant Survivorship
timeFrame: 1,5 and 10 years
measure: Relative change of Range of Motion (ROM) compared to baseline
timeFrame: up to 10 years
measure: Relative change of Constant-Murley Score (CMS) compared to baseline
timeFrame: up to 10 years
measure: Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline
timeFrame: up to 10 years
measure: Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline
timeFrame: up to 10 years
measure: Relative change of Simple Shoulder Test (SST) compared to baseline
timeFrame: up to 10 years
measure: Relative change of Pain compared to baseline
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Columbia
country: United States
facility: John Hopkins University
state: Maryland
city: Starkville
country: United States
facility: Mississipi Bone and Joint Clinic
state: Mississippi
city: Syracuse
country: United States
facility: The Research Foundation for The State University of New York (SUNY)
state: New York
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
Study officials:
References: