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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inverse / Reverse Shoulder | Experimental | Patient treated with a inverse / reverse shoulder device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inverse/Reverse Shoulder Arthroplasty | Procedure | Implantation of the Anatomical Shoulder Inverse/Reverse System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliott Goff, PhD | Zimmer Biomet, Jr. Clinical Project Lead | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Monica Antwerpen | Antwerp | Belgium | ||||
| HELIOS ENDO-Klinik Hamburg |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anatomical Shoulder Inverse/Reverse Prosthesis | Subjects implanted with the Anatomical Shoulder Inverse/reverse prosthesis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
154 participants were enrolled with signed informed consent whereas only 153 participants received the study device. 153 is the number that serves for the final analysis
| ID | Title | Description |
|---|---|---|
| BG000 | Inverse / Reverse Shoulder | Patient treated with a inverse / reverse shoulder device. Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 153 is the number for the analysis |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | For 42 participants constant & Murley score were available from baseline to 10 years follow-up. | Posted | Mean | Standard Deviation | score on a scale | 10 years | Implants | Implants |
|
|
AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inverse / Reverse Shoulder | Patient treated with a inverse / reverse shoulder device. Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to unrelated reasons | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elliott Goff | Zimmer Biomet | +41 79 222 23 08 | elliott.goff@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2012 | Apr 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Hamburg |
| Germany |
| Vitos Orthopädische Klinik Kassel | Kassel | Germany |
| Uniklinik Balgrist | Zurich | Switzerland |
| The Pennine Acute Hospital NHS Trust | Manchester | United Kingdom |
| Did not receive study device |
|
| implants |
|
| Mean |
| Standard Deviation |
| years |
| Participants |
|
|
| Sex: Female, Male | 155 participants were enrolled, 153 serve as basis for the analysis | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | 155 participants were enrolled, only 153 cases were operated with the study device and serve for the final results. | Number | participants | Participants |
|
|
| BMI | 155 participants were enrolled but the analysis of results are based on 153 participants implanted with the study device | Mean | Standard Deviation | kg/m2 | Participants |
|
|
| Height | 155 participants were enrolled but 153 participants that received the study device were included in the analysis | 153 is the number of participants receiving the study device , this number serves the final analysis | Mean | Standard Deviation | cm | Participants |
|
|
| Weight | 153 participants received the study device and serve as the final analysis | Mean | Standard Deviation | kg | Participants |
|
|
| Counts |
|---|
| Participants |
|
| Implants |
|
|
| 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. | Posted | Count of Units | Implants | 10 years | Implants | Implants |
|
|
|
| 26 |
| 153 |
| 58 |
| 153 |
| 0 |
| 0 |
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fracture of femoral neck | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fracture of proximal humerus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Glenoid implant failure | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Glenoid implant loosening | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| humeral implant loosening | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nerve deficit | Nervous system disorders | Non-systematic Assessment |
|
| nerve injury | Nervous system disorders | Non-systematic Assessment |
|
| Other general complication (not shoulder) | General disorders | Non-systematic Assessment |
|
| Other shoulder related complication | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wound dehiscence | Surgical and medical procedures | Non-systematic Assessment |
|
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| D000070657 |
| Crystal Arthropathies |