Failed Hemi-arthroplasty, Failed Total Shoulder, Rotator Cuff Arthropathy
Conditions
Brief summary
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.
Interventions
DEVICEReverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
Sponsors
Encore Medical, L.P.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff * Evidence of upward displacement of the humeral head with respect to the glenoid * Loss of glenohumeral joint space * Functional deltoid muscle * Patient is likely to be available for evaluation for the duration of the study * Visual Analog Pain Scale 5 or greater
Exclusion criteria
* Non functional deltoid muscle * Active sepsis * Excessive glenoid bone loss * Pregnancy * Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity. * Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease. * Prisoners * Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity). * Known metal allergy (i.e., jewelry). * Visual Analog Pain Scale \<5.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score | 2-year | The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: \[(10 - Visual analog scale pain score) x 5\] + \[(5/3) x Cumulative ADL score\] |
| Average Range of Motion | 2-year | Physician's assessment of a subject's range of motion in degrees. |
| Subject Satisfaction With Surgery | 2-year | Each subject had a chance to rate their satisfaction with surgery at each study interval. |
| Have Surgery Again? | 2-year | Subject satisfaction: subject's willingness to have surgery performed again if necessary. |
| Neer's Limited Goals | 2-year | To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit \>90 degrees active forward elevation and exhibit \>20 degrees of active external rotation. |
| Radiographic Failures | Post-operative, 3-month, 6-month, 1-year, 2-year | Radiographic failure is defined as a shift in the position of the component \>3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a \>2mm radiolucency completely around either prosthesis. |
| Safety Assessment | 2-year | Number of device related adverse events and device failures at the 2 year time frame. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. | 141 |
| Revision Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device. | 141 |
| Continued Access Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder. | 234 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 12 | 6 | 13 |
| Overall Study | Lost to Follow-up | 40 | 34 | 72 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Revision of Device | 12 | 23 | 14 |
| Overall Study | Withdrawal by Subject | 1 | 7 | 4 |
Baseline characteristics
| Characteristic | Total | Primary | Revision | Continued Access |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 377 Participants | 111 Participants | 89 Participants | 177 Participants |
| Age, Categorical Between 18 and 65 years | 139 Participants | 30 Participants | 52 Participants | 57 Participants |
| Age Continuous | 70.4 years STANDARD_DEVIATION 10.1 | 71.9 years STANDARD_DEVIATION 9.5 | 67.4 years STANDARD_DEVIATION 11.6 | 71.2 years STANDARD_DEVIATION 9.2 |
| Operative Shoulder Left | 200 participants | 54 participants | 58 participants | 88 participants |
| Operative Shoulder Right | 316 participants | 87 participants | 83 participants | 146 participants |
| Region of Enrollment United States | 516 participants | 141 participants | 141 participants | 234 participants |
| Sex: Female, Male Female | 320 Participants | 87 Participants | 97 Participants | 136 Participants |
| Sex: Female, Male Male | 196 Participants | 54 Participants | 44 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 116 / 156 | 113 / 162 | 157 / 249 |
| serious Total, serious adverse events | 0 / 156 | 0 / 162 | 0 / 249 |
Outcome results
Primary
American Shoulder and Elbow Surgeons Shoulder Score
The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: \[(10 - Visual analog scale pain score) x 5\] + \[(5/3) x Cumulative ADL score\]
Time frame: 2-year
Population: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary | American Shoulder and Elbow Surgeons Shoulder Score | 76 Units on a scale | Standard Deviation 18.5 |
| Revision | American Shoulder and Elbow Surgeons Shoulder Score | 62 Units on a scale | Standard Deviation 18.5 |
| Continued Access | American Shoulder and Elbow Surgeons Shoulder Score | 77 Units on a scale | Standard Deviation 18.1 |
Primary
Average Range of Motion
Physician's assessment of a subject's range of motion in degrees.
Time frame: 2-year
Population: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary | Average Range of Motion | Active external rotation | 33.3 Angle of Degrees of Shoulder Motion | Standard Deviation 19 |
| Primary | Average Range of Motion | Active forward elevation | 119.6 Angle of Degrees of Shoulder Motion | Standard Deviation 39.3 |
| Primary | Average Range of Motion | Active cross body adduction | 25.8 Angle of Degrees of Shoulder Motion | Standard Deviation 18.6 |
| Revision | Average Range of Motion | Active external rotation | 23.3 Angle of Degrees of Shoulder Motion | Standard Deviation 18.7 |
| Revision | Average Range of Motion | Active forward elevation | 84.4 Angle of Degrees of Shoulder Motion | Standard Deviation 36.5 |
| Revision | Average Range of Motion | Active cross body adduction | 13.9 Angle of Degrees of Shoulder Motion | Standard Deviation 15.6 |
| Continued Access | Average Range of Motion | Active forward elevation | 120.4 Angle of Degrees of Shoulder Motion | Standard Deviation 34.7 |
| Continued Access | Average Range of Motion | Active cross body adduction | 27.4 Angle of Degrees of Shoulder Motion | Standard Deviation 20.6 |
| Continued Access | Average Range of Motion | Active external rotation | 37.1 Angle of Degrees of Shoulder Motion | Standard Deviation 24.2 |
Primary
Have Surgery Again?
Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Time frame: 2-year
Population: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary | Have Surgery Again? | Yes | 52 participants |
| Primary | Have Surgery Again? | No | 7 participants |
| Revision | Have Surgery Again? | Yes | 40 participants |
| Revision | Have Surgery Again? | No | 9 participants |
| Continued Access | Have Surgery Again? | Yes | 88 participants |
| Continued Access | Have Surgery Again? | No | 10 participants |
Primary
Neer's Limited Goals
To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit \>90 degrees active forward elevation and exhibit \>20 degrees of active external rotation.
Time frame: 2-year
Population: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary | Neer's Limited Goals | No - criteria not met | 26 participants |
| Primary | Neer's Limited Goals | Yes - criteria met | 33 participants |
| Revision | Neer's Limited Goals | No - criteria not met | 40 participants |
| Revision | Neer's Limited Goals | Yes - criteria met | 9 participants |
| Continued Access | Neer's Limited Goals | Yes - criteria met | 59 participants |
| Continued Access | Neer's Limited Goals | No - criteria not met | 39 participants |
Primary
Radiographic Failures
Radiographic failure is defined as a shift in the position of the component \>3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a \>2mm radiolucency completely around either prosthesis.
Time frame: Post-operative, 3-month, 6-month, 1-year, 2-year
Population: Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary | Radiographic Failures | 0 participants |
| Revision | Radiographic Failures | 0 participants |
| Continued Access | Radiographic Failures | 0 participants |
Primary
Safety Assessment
Number of device related adverse events and device failures at the 2 year time frame.
Time frame: 2-year
Population: Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary | Safety Assessment | Number of device related adverse events | 27 adverse events |
| Primary | Safety Assessment | Revisions of device | 12 adverse events |
| Primary | Safety Assessment | Total number of operative site adverse events | 87 adverse events |
| Revision | Safety Assessment | Number of device related adverse events | 25 adverse events |
| Revision | Safety Assessment | Revisions of device | 23 adverse events |
| Revision | Safety Assessment | Total number of operative site adverse events | 117 adverse events |
| Continued Access | Safety Assessment | Revisions of device | 14 adverse events |
| Continued Access | Safety Assessment | Total number of operative site adverse events | 91 adverse events |
| Continued Access | Safety Assessment | Number of device related adverse events | 14 adverse events |
Primary
Subject Satisfaction With Surgery
Each subject had a chance to rate their satisfaction with surgery at each study interval.
Time frame: 2-year
Population: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary | Subject Satisfaction With Surgery | Unsatisfactory | 4 participants |
| Primary | Subject Satisfaction With Surgery | Excellent | 31 participants |
| Primary | Subject Satisfaction With Surgery | Good | 18 participants |
| Primary | Subject Satisfaction With Surgery | Satisfactory | 6 participants |
| Revision | Subject Satisfaction With Surgery | Satisfactory | 13 participants |
| Revision | Subject Satisfaction With Surgery | Unsatisfactory | 4 participants |
| Revision | Subject Satisfaction With Surgery | Good | 12 participants |
| Revision | Subject Satisfaction With Surgery | Excellent | 20 participants |
| Continued Access | Subject Satisfaction With Surgery | Satisfactory | 9 participants |
| Continued Access | Subject Satisfaction With Surgery | Excellent | 60 participants |
| Continued Access | Subject Satisfaction With Surgery | Good | 27 participants |
| Continued Access | Subject Satisfaction With Surgery | Unsatisfactory | 2 participants |