Cuff-tear Arthropathy
Conditions
Keywords
Inverse Reverse Shoulder
Brief summary
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs. Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided: • Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.
Detailed description
This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria. All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge. There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.
Interventions
PROCEDUREInverse/Reverse Shoulder Arthroplasty
Implantation of the Anatomical Shoulder Inverse/Reverse System
Sponsors
Zimmer, GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age - 18 years minimum. * Sex - male and female. * General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history. * Informed Consent - patient or patient's legal representative has signed a Patient Informed Consent form. * Indications - Diagnosis of disease or trauma in the affected joint, including cuff-tear arthropathy, failure of prior rotator cuff surgery and irreparable rotator cuff tears associated with loss of glenohumeral stability with the indication for total shoulder arthroplasty. * The deltoid muscle has to be intact in all 3 parts (clavicular, acromial as well as spinal).
Exclusion criteria
* Patient is skeletally immature. * Patient is pregnant. * Patient is unwilling or unable to cooperate in a follow-up program. * Patient shows one of the following medical conditions - Chronic fracture, Acute fracture, Axillary nerve lesion, Severe loss of humeral or glenoid bone, Paralysis of the deltoid muscle, Active Infection * Patient requires one of the following medical interventions - Implant Revision, Glenoid bone grafting, Autografts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Performance | 10 years | Constant & Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival (Kaplan-Meier) | 10 years | The Kaplan-Meier estimator is a non-parametric statistic used to estimate the survival function from lifetime data. It is used to measure the fraction of patients living (in this case without a revision surgery) for a certain amount of time after treatment. A higher score is a better outcome. |
Countries
Belgium, Germany, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inverse / Reverse Shoulder Patient treated with a inverse / reverse shoulder device.
Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System | 153 |
| Inverse / Reverse Shoulder Patient treated with a inverse / reverse shoulder device.
Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System | 153 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 26 |
| Overall Study | Did not receive study device | 1 |
| Overall Study | Lost to Follow-up | 60 |
| Overall Study | Revision | 6 |
Baseline characteristics
| Characteristic | Inverse / Reverse Shoulder |
|---|---|
| Age, Continuous | 74.4 years STANDARD_DEVIATION 6.1 |
| BMI | 27.2 kg/m2 STANDARD_DEVIATION 4.5 |
| Height | 165.0 cm STANDARD_DEVIATION 8.4 |
| Region of Enrollment Belgium | 19 participants |
| Region of Enrollment Germany | 71 participants |
| Region of Enrollment Switzerland | 50 participants |
| Region of Enrollment United Kingdom | 13 participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 56 Participants |
| Weight | 74.1 kg STANDARD_DEVIATION 14.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 26 / 153 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 58 / 153 |
Outcome results
Primary
Functional Performance
Constant & Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
Time frame: 10 years
Population: For 42 participants constant \& Murley score were available from baseline to 10 years follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inverse / Reverse Shoulder | Functional Performance | 57.9 score on a scale | Standard Deviation 15.8 |
Secondary
Survival (Kaplan-Meier)
The Kaplan-Meier estimator is a non-parametric statistic used to estimate the survival function from lifetime data. It is used to measure the fraction of patients living (in this case without a revision surgery) for a certain amount of time after treatment. A higher score is a better outcome.
Time frame: 10 years
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Inverse / Reverse Shoulder | Survival (Kaplan-Meier) | 147 Implants |