An interventional study of Inverse/Reverse Shoulder Arthroplasty in Cuff-tear Arthropathy, sponsored by Zimmer, GmbH. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Zimmer, GmbH · Not applicable, Interventional, and Treatment
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:
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.
52 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
This study's enrollment of 154 is above the median of 93 across 29 interventional studies indexed under Rotator Cuff Tear Arthropathy.
Browse Rotator Cuff Tear Arthropathy studies →Zimmer, GmbH is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient treated with a inverse / reverse shoulder device.
Procedure: Inverse/Reverse Shoulder Arthroplasty
Implantation of the Anatomical Shoulder Inverse/Reverse System
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
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
| Milestone | Anatomical Shoulder Inverse/Reverse Prosthesis |
|---|---|
| Started | 154 |
| Received study device | 153 |
| Completed | 61 |
| Not completed | 93 |
| Withdrew: Death | 26 |
| Withdrew: Revision | 6 |
| Withdrew: Lost to follow-up | 60 |
| Withdrew: Did not receive study device | 1 |
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.
| score on a scale | Inverse / Reverse Shoulder |
|---|---|
| Functional Performance | 57.9 ± 15.8 |
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.
| Implants | Inverse / Reverse Shoulder |
|---|---|
| Survival (Kaplan-Meier) | 147 |
Collected over AEs were collected from the time of surgery until study completion (up to 10 years). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inverse / Reverse Shoulder | 26/153 (17%) | 58/153 (37.9%) | — |
| Event | Inverse / Reverse Shoulder |
|---|---|
| Death due to unrelated reasonsGeneral disorders | 26/153 |
| Other general complication (not shoulder)General disorders | 16/153 |
| Fracture of proximal humerusMusculoskeletal and connective tissue disorders | 5/153 |
| Other shoulder related complicationMusculoskeletal and connective tissue disorders | 4/153 |
| Glenoid implant looseningMusculoskeletal and connective tissue disorders | 3/153 |
| Cardiac ArrhythmiaCardiac disorders | 2/153 |
| DislocationMusculoskeletal and connective tissue disorders | 2/153 |
| hematomaBlood and lymphatic system disorders | 2/153 |
| AnemiaBlood and lymphatic system disorders | 1/153 |
| Fracture of femoral neckMusculoskeletal and connective tissue disorders | 1/153 |
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
| Age, Continuous(years) | Inverse / Reverse Shoulder |
|---|---|
| Mean | 74.4 ± 6.1 |
| Sex: Female, Male(Participants) | Inverse / Reverse Shoulder |
|---|---|
| Female | 97 |
| Male | 56 |
| Race and Ethnicity Not Collected(Participants) | Inverse / Reverse Shoulder |
|---|
| Region of Enrollment(participants) | Inverse / Reverse Shoulder |
|---|---|
| Belgium | 19 |
| United Kingdom | 13 |
| Switzerland | 50 |
| Germany | 71 |
| BMI(kg/m2) | Inverse / Reverse Shoulder |
|---|---|
| Mean | 27.2 ± 4.5 |
| Height(cm) | Inverse / Reverse Shoulder |
|---|---|
| Mean | 165.0 ± 8.4 |
| Weight(kg) | Inverse / Reverse Shoulder |
|---|---|
| Mean | 74.1 ± 14.3 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rotator Cuff Tear Arthropathy→
Zimmer, GmbH