Osteoarthritis
Conditions
Brief summary
A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.
Detailed description
The purpose of this study is to demonstrate non-inferiority of the Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. Non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.
Interventions
DEVICEUnivers™
Control
DEVICEEclipse™ Total Shoulder Replacement
Investigational
Sponsors
Arthrex, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is \> 21 years of age * The subject has continued symptoms in target shoulder despite at least 3 months of other treatment modalities(e.g.: anti-inflammatory, physical therapy and steroid injections) * The subject has a diagnosis in the target shoulder of one or more of the following: osteoarthritis, avascular necrosis, post-traumatic arthritis, or rheumatoid arthritis. * The subject presents with pain and functional impairment in the index shoulder, measured by an Adjusted Constant Score of ≤50. Note: The Adjusted Constant Score will be calculated from the raw Constant Score to establish patient eligibility. * The subject is willing to receive implantation of the Arthrex™ Shoulder Prosthesis or Univers™ II Shoulder Prosthesis. * The subject must be physically and mentally willing and able to comply with all study procedures (including follow-up visits and radiographic assessments) until the conclusion of the study. * The subject has been informed of the nature of the study and provided written consent as approved by the sites local Institutional Review Board or Ethic Review Board.
Exclusion criteria
* The subject is likely a candidate for hemi-humeral arthroplasty (i.e.: Avascular Necrosis of the humeral head without glenoid involvement (Stages 0-3): Rotator Cuff Deficient Shoulder: Glenoid Bone deficiency/deformity that precludes glenoid replacement (Walch Type B2 or C) or Fractures of the Proximal Humerus, without Glenoid involvement. * The subject has immature bone as defined by the absence of cancellous bone patterning, a mature, thick cortex, and stress lines within the cancellous bone. * The subject has obvious defects in bone quality, such as cysts or lesions, in the humeral head of the target shoulder, as demonstrated by radiographic evaluation. * The subject has a target shoulder a rotator cuff that is not intact and not reconstructible. * The subject has Irreducible 3- and 4- part proximal humeral fractures of the target shoulder. * The subject has documented history of foreign-body sensitivity. * Subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period * The subject has history of Schizophrenia, Bipolar Disorder and/or Major Depressive Disorder as defined by DSM IV. * The subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses. * The subject is at high risk for poor healing or confounding outcomes \[(i.e.: clinically significant renal, hepatic, cardiac hematologic disease or endocrine disease)\] * The subject is on immune-stimulating or immunosuppressive agents * The subject has co-morbidity that reduces life expectancy \< 36 month. * The subject seeking or receiving workman's compensation for shoulder injury, * The subject is \> 350 lbs. * The subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.) * The subject has had surgery in the affected shoulder in the last 12 months (with the exception of diagnostic arthroscopy without reconstruction or repair procedures) * The subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports) * The subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids with the exception of topical and/or inhalers) * The subject is a prisoners or wards of the state * The subject has a history of alcohol and/or substance abuse as defined by DSM IV (Diagnostic and Statistical Manual Diploma in Social Medicine) * The subject has an active or chronic infection, either systemic or local. * The subject has pathologic fractures of the affected shoulder * The subject has acute trauma of the affected shoulder * The subject has osteoporosis defined as a bone density T score of \< or = -2.5. (A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) and MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients who require a DEXA (dual energy x-ray absorptiometry) bone mineral density measurement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Clinical Success | 2 year | To be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is \> or = to 10 and a final Adjusted Constant Score \> or + to 54. 2. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. 3. No reoperation, removal or modification of any study component up to the subject's completion of the study. 4. No serious device-related complications up to the subject's completion of the study. |
Countries
United States
Participant flow
Recruitment details
In February 2013, the first subject was enrolled in the study and the last subject was enrolled in August 2018. Subjects were enrolled at both academic and private study sites.
Pre-assignment details
The treated population was 303 subject, with 224 Eclipse subjects and 79 Univers II subjects.
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator: Univer II Univer II Total Shoulder Replacement | 79 |
| Experimental: Eclipse Eclipse Total shoulder Replacement | 224 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 7 |
| Overall Study | Study ended due to FDA clearance | 1 | 68 |
Baseline characteristics
| Characteristic | Active Comparator: Univer II | Experimental: Eclipse | Total |
|---|---|---|---|
| Age, Continuous | 66 years | 66 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 79 Participants | 220 Participants | 299 Participants |
| Region of Enrollment United States | 79 Participants | 224 Participants | 303 Participants |
| Sex: Female, Male Female | 22 Participants | 66 Participants | 88 Participants |
| Sex: Female, Male Male | 57 Participants | 158 Participants | 215 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 1 / 224 |
| other Total, other adverse events | 42 / 79 | 54 / 224 |
| serious Total, serious adverse events | 12 / 79 | 26 / 224 |
Outcome results
Primary
Composite Clinical Success
To be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is \> or = to 10 and a final Adjusted Constant Score \> or + to 54. 2. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. 3. No reoperation, removal or modification of any study component up to the subject's completion of the study. 4. No serious device-related complications up to the subject's completion of the study.
Time frame: 2 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Univer™ II | Composite Clinical Success | 89.7 percentage of success rate |
| Eclipse™ | Composite Clinical Success | 92.3 percentage of success rate |