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| Name | Class |
|---|---|
| Universität Münster | OTHER |
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The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.
see Protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPF | patients treated with locked plate fixation | ||
| RTSA | reverse total shoulder arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTSA | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | Death from any cause during the first 30-days after surgery. | 30 days |
| Overall survival (OS) | Time from discharge of index hospitalization to death of any case. | up to 12 years |
| Major adverse events during index case | See above, only events during hospitalization | through hospital stay, an average of 16 days |
| Major adverse events after discharge | Time from discharge of index hospitalization to MAE as defined above | up to 12 years |
| Thromboembolic events during index | See above, only events during hospitalization | through hospital stay, an average of 16 days |
| Thromboembolic events (or death) after discharge | Time from discharge of index hospitalization to a thromboembolic event or death of any case. | up to 12 years |
| Surgical complications during index case | See above, only events during hospitalization | through hospital stay, an average of 16 days |
| Surgical complications after discharge | Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant-associated complication during index | See above, only events during hospitalization | through hospital stay, an average of 16 days |
| Non-Implant-associated complication during index | See above, only events during hospitalization |
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Inclusion Criteria:
- all patients will be included, who had an inpatient coded treatment using LPF or RTSA
Exclusion Criteria:
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Patients were grouped into two treatment groups: LPF (reference group) or RTSA depending on which therapy was performed first. If RTSA and LPF were coded at the same day, patients were assigned to RTSA group. Two different analysis sets were defined as follows:
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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 | Mar 8, 2023 | Jul 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| up to 12 years |
| through hospital stay, an average of 16 days |
| Minor outpatient complications after discharge | Time from discharge of index hospitalization to minor outpatient complications, with death being considered as a competing risk event. | up to 12 years |