A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Joint Disease
- Sponsor
- Zimmer Biomet
- Enrollment
- 258
- Locations
- 12
- Primary Endpoint
- American Shoulder and Elbow Surgeon's Score (ASES)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
Detailed Description
The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer): 1. American Shoulder and Elbow Surgeons (ASES) Score 2. Single Assessment Numeric Evaluation (SANE) 3. Constant Score 4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence 5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients for whom the surgeon has confirmed intraoperatively, has no cyst \> 1cm and not more than one cyst at the implantation site
- •Patients with non-inflammatory degenerative joint disease including osteoarthritis.
- •Patients where the device will be used in the correction of a functional deformity (deformities preventing congruent articulation of the glenohumeral joint)
- •Patients with pain and/or loss of function in the shoulder for whom other treatment modalities have been unsuccessful.
- •Patients requiring unilateral or staged bilateral shoulder arthroplasty
- •Patient must be anatomically and structurally suited to receive the implants (humeral neck must be of sufficient diameter to implant at least the smallest nano humeral component and the humeral neck is intact).
- •Patients who are 21-90 years of age at the time of surgery and have reached skeletal maturity.
- •Patients with an ASES score ≤ 40.
Exclusion Criteria
- •Patients diagnosed with avascular necrosis or post-traumatic arthritis of the humeral head
- •Patients found at the time of intraoperative examination to have a single cyst \>1 cm in size or multiple cysts at the implantation site
- •Patient presents with shoulder joint infection, sepsis, osteomyelitis or distant foci of infections which may spread to the implant site.
- •Patients with cuff tear arthropathy.
- •Patients who have undergone a Hemi-, Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.
- •Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.
- •Patients with osteoporosis, osteomalacia, rheumatoid arthritis, metabolic disorders of bone, muscle or connective tissue, gross deformity or any other condition of the proximal humerus (defined as severe destruction or deformity of the proximal humerus that precludes placement of the device) that in the Investigator's medical judgment could compromise implant fixation or bone healing.
- •Rapid bone destruction, marked bone loss or bone resorption apparent on roentgenogram.
- •Patients with neurologic or other disorders that would either affect the stability of the shoulder prosthesis, i.e., Charcot's joint, uncontrolled seizures, etc., or would affect their capability or willingness to return to the clinic for assessments and/or follow directions.
- •Bone cancer, either primary or secondary, that affects the shoulder.
Outcomes
Primary Outcomes
American Shoulder and Elbow Surgeon's Score (ASES)
Time Frame: 22+ Months
The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.
Number of Shoulders With Radiographic Success
Time Frame: 2 years
This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "Subsidence of the humeral component \<5 mm, and migration of the humeral component \<5 mm, and no progressive lucency around the humeral component \>2 mm in two or more contiguous zones, and migration of the glenoid component \<5 mm, and no progressive lucency \>2 mm around the entire glenoid component." All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria.
Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation
Time Frame: 2 years
This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component." All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data.
Secondary Outcomes
- Constant Score Adjusted for Age and Gender(Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years)
- Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence(2+ years)
- American Shoulder and Elbow Surgeon's Score (ASES)(Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years)
- Single Assessment Numeric Evaluation (SANE) Score(6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years)