Arthropathy, Arthroplasty Complications, Rotator Cuff Injuries, Shoulder Pain
Conditions
Brief summary
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
Detailed description
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, survival, and radiographic parameters of all enrolled study subjects. The primary endpoint is defined by the survival of the implant system at 2 years which is based on removal or intended removal of the Anaverse™ Glenoid System baseplate and will be determined by using the Kaplan Meier method.
Interventions
DEVICEAnaverse Shoulder System
Reverse Shoulder Arthroplasty
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Patient is 18-75 years of age, inclusive. * Patient is skeletally mature. * Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program. * Patient must have signed EC-approved informed consent. * Patient requires a primary reversed total shoulder arthroplasty or a conversion from anatomical to reversed to relieve pain and restore the joint function. * Patient has adequate quality and quantity of bone stock to support the prosthesis. * Patient meets at least one of the following indications: * Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis * Conditions consequent to earlier operations * Omarthrosis or Osteoarthritis * Rheumatoid arthritis * Total joint reconstruction following trauma * Patient has significant shoulder disability due to gross and irreparable rotator cuff deficiency. A functional deltoid muscle is necessary to use the device. * Patient underwent reverse total shoulder reconstruction with the Anaverse Glenoid System before the date of site initiation. * Patient has demographic, pre-operative evaluation, operative report and device information available. Specific inclusion criteria for Conversion from Anatomical to Reversed Configuration: * Surgery was performed with the Anaverse Glenoid System in a previously available anatomical configuration. * Irreparable rotator cuff with superior migration of the humeral head, leading to a reduction in sub-acromial space. * Superior tilt of the Anaverse Glenoid Baseplate not exceeding 15° compared to scapular axis. * No evidence of mechanical or fixation failure of the Baseplate, TM Pegs or DPSC Screws, obtained pre- or intra-operatively, which would compromise the success of the conversion surgery.
Exclusion criteria
* Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient has any condition which would in the judgment of the Investigator place the patient at undue risk or interfere with the study. * Patient is known to be pregnant or breastfeeding. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant). * Patient has any physical conditions that would impair adequate implant support and/or prevent the use of an appropriately sized implant. * Patient has any sign of infection (affecting the shoulder joint or in its proximity). * Patient has glenoid presenting with large defects due to erosion, which would lead to insufficient bony support or malalignment of the devices. * Patient is skeletally immature. * Patient has any sign of neuromuscular compromise (excluding rotator cuff tear). * Patient has vascular deficiency in the affected limb in sufficient degree to endanger the success of the intervention. * Patient has absence of musculo-ligamentous supporting structures. * Patient suffers from joint neuropathy or other conditions that may lead to inadequate skeletal fixation. * Patient has significant injury to the upper brachial plexus. * Patient has non-functional deltoid muscle. Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of Implant System (Kaplan Meier) | 2 years post-op | The primary endpoint of this study is the survival of the implant (Reversed configuration) after 2 years, which is based on removal of the baseplate and will be determined using the Kaplan-Meier method. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Constant Murley Shoulder Score (CM) | Pre-operative (baseline), 1 year, 2 years post-operative | The Constant Murley (CM) Score comprises outcome measures of freedom from pain (15 points), full range of function (20 points), active range of movement (40 points), and full strength (25 points). The total score is an aggregate of the individual outcome measures. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome). |
| Subjective Shoulder Value (SSV) | Pre-operative (baseline), 1 year, 2 years post-operative | The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal. |
| Radiographic Parameters | Immediate post-op to 2 years post-operative | Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral implant subsidence / glenoid component migration), heterotopic ossification and scapular notching |
Countries
Switzerland
Participant flow
Pre-assignment details
Recruitment was terminated prematurely due to early termination of the study due to product rationalization for commercial reasons. 20 participants (21 cases) of the 30 planned cases were included.
Participants by arm
| Arm | Count |
|---|---|
| Anaverse Shoulder System Subjects Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed.
Anaverse Shoulder System: Reverse Shoulder Arthroplasty | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Anaverse Shoulder System Subjects | — |
|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 8.6 | — |
| Height | 168.3 cm STANDARD_DEVIATION 10.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Switzerland | 20 Participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Weight | 80.7 kg STANDARD_DEVIATION 16.1 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Survival of Implant System (Kaplan Meier)
The primary endpoint of this study is the survival of the implant (Reversed configuration) after 2 years, which is based on removal of the baseplate and will be determined using the Kaplan-Meier method.
Time frame: 2 years post-op
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Anaverse Shoulder System Subjects | Survival of Implant System (Kaplan Meier) | 20 Implants |
Other Pre-specified
Constant Murley Shoulder Score (CM)
The Constant Murley (CM) Score comprises outcome measures of freedom from pain (15 points), full range of function (20 points), active range of movement (40 points), and full strength (25 points). The total score is an aggregate of the individual outcome measures. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).
Time frame: Pre-operative (baseline), 1 year, 2 years post-operative
Population: * preoperative and 1-year data was collected retrospectively, therefore number number analyzed in the rows might differ from overall number analyzed~* 1 patient completed study participation prior to the 2 years follow-up due to revision surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anaverse Shoulder System Subjects | Constant Murley Shoulder Score (CM) | 2 years | 71.0 score on a scale | Standard Deviation 8.9 |
| Anaverse Shoulder System Subjects | Constant Murley Shoulder Score (CM) | Preop | 26.5 score on a scale | Standard Deviation 13.5 |
| Anaverse Shoulder System Subjects | Constant Murley Shoulder Score (CM) | 1 year | 65.4 score on a scale | Standard Deviation 17 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Radiographic Parameters
Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral implant subsidence / glenoid component migration), heterotopic ossification and scapular notching
Time frame: Immediate post-op to 2 years post-operative
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Anaverse Shoulder System Subjects | Radiographic Parameters | Radiolucency - Humerus ≥ 2mm | Yes | 1 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Radiolucency - Humerus ≥ 2mm | No | 20 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Radiolucency - Glenoid | Yes | 0 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Radiolucency - Glenoid | No | 21 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Osteolysis - Humerus ≥ 2mm | Yes | 1 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Osteolysis - Humerus ≥ 2mm | No | 20 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Osteolysis - Glenoid | Yes | 0 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Osteolysis - Glenoid | No | 21 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Atrophy | Yes | 0 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Atrophy | No | 21 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Hypertrophy | Yes | 0 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Hypertrophy | No | 21 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Osteophytes (Glenoid) | Yes | 6 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Osteophytes (Glenoid) | No | 15 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Component Migration (humeral implant subsidence / glenoid component migration) | Yes | 0 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Component Migration (humeral implant subsidence / glenoid component migration) | No | 21 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Heterotopic Ossification - Grade 1 | Yes | 4 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Heterotopic Ossification - Grade 1 | No | 17 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Heterotopic Ossification - Grade 2 | Yes | 1 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Heterotopic Ossification - Grade 2 | No | 20 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Heterotopic Ossification - Grade 3-4 | Yes | 0 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Heterotopic Ossification - Grade 3-4 | No | 21 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Scapular Notching - Grade 1 | Yes | 7 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Scapular Notching - Grade 1 | No | 14 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Scapular Notching - Grade 2-4 | Yes | 0 Implants |
| Anaverse Shoulder System Subjects | Radiographic Parameters | Scapular Notching - Grade 2-4 | No | 21 Implants |
Other Pre-specified
Subjective Shoulder Value (SSV)
The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal.
Time frame: Pre-operative (baseline), 1 year, 2 years post-operative
Population: * preoperative and 1-year data was collected retrospectively, therefore number number analyzed in the rows might differ from overall number analyzed~* 1 patient completed study participation prior to the 2 years follow-up due to revision surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anaverse Shoulder System Subjects | Subjective Shoulder Value (SSV) | Preop | 28.3 percentage of normal | Standard Deviation 17.5 |
| Anaverse Shoulder System Subjects | Subjective Shoulder Value (SSV) | 1 year | 85.5 percentage of normal | Standard Deviation 11.9 |
| Anaverse Shoulder System Subjects | Subjective Shoulder Value (SSV) | 2 years | 85.7 percentage of normal | Standard Deviation 14 |
p-value: <0.001t-test, 2 sided