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Anatomical Shoulder™ Inverse/Reverse Study
NA trial testing Inverse/Reverse Shoulder Arthroplasty in Cuff-tear Arthropathy in 154 participants. Completed in 11 March 2024.
| Lead sponsor | Zimmer, GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 154 |
| Start date | 16 May 2007 |
| Primary completion | 16 February 2022 |
| Estimated completion | 11 March 2024 |
| Sites | 5 locations across Belgium, United Kingdom, Switzerland, Germany |
Zimmer, GmbH
18 and older, any sex, with Cuff-tear Arthropathy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Inverse / Reverse Shoulder | 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.
| Group | Value | 95% CI |
|---|---|---|
| Inverse / Reverse Shoulder | 147 |
Time frame: AEs were collected from the time of surgery until study completion (up to 10 years). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Inverse / Reverse Shoulder |
|---|---|---|
| Death due to unrelated reasons | General disorders | — |
| Other general complication (not shoulder) | General disorders | — |
| Fracture of proximal humerus | Musculoskeletal and connective tissue disorders | — |
| Other shoulder related complication | Musculoskeletal and connective tissue disorders | — |
| Glenoid implant loosening | Musculoskeletal and connective tissue disorders | — |
| Cardiac Arrhythmia | Cardiac disorders | — |
| Dislocation | Musculoskeletal and connective tissue disorders | — |
| hematoma | Blood and lymphatic system disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Fracture of femoral neck | Musculoskeletal and connective tissue disorders | — |
| Glenoid implant failure | Musculoskeletal and connective tissue disorders | — |
| hemorrhage | Blood and lymphatic system disorders | — |
| humeral implant loosening | Musculoskeletal and connective tissue disorders | — |
| Nerve deficit | Nervous system disorders | — |
| nerve injury | Nervous system disorders | — |
| respiratory infection | Respiratory, thoracic and mediastinal disorders | — |
| Wound dehiscence | Surgical and medical procedures | — |
Most-reported serious reactions: Death due to unrelated reasons, Other general complication (not shoulder), Fracture of proximal humerus, Other shoulder related complication, Glenoid implant loosening, Cardiac Arrhythmia, Dislocation, hematoma.
Data from ClinicalTrials.gov NCT02466321 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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