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| Name | Class |
|---|---|
| Herlev and Gentofte Hospital | OTHER |
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The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTSA group | Experimental | Participants with a complex proximal humerus fracture given a RTSA |
|
| Hemiarthroplasty group | Active Comparator | Historical cohort of participants, operated with a hemiarthroplasty of the shoulder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reverse Total Shoulder Arthroplasty | Device | The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Constant score (CS) | The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxford Shoulder Score (OSS) | The OSS is a patient related outcome-measure (PROM) validated for evaluating self-assessed functionality after shoulder surgery. The 12 questions, with five response options, gives a total score ranging from 12 points (no pain or functional impairment) to 60 points (worst). | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Signe R Rasmussen, MD | Contact | +4526623427 | signe.nanna.rosner.rasmussen.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Bo S Olsen, Professor | Herlev and Gentofte Hospital | Study Chair |
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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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| ID | Term |
|---|---|
| D062785 | Hemiarthroplasty |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Hemiarthroplasty | Device | The shoulder hemiarthroplasty |
|
| Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS) | The WOOS is a patient-related outcome measurement, initially validated for patients with osteoarthritis of the shoulder. On four domains (physical symptoms, recreation/work, lifestyle, emotions) the visual analog scale measures shoulder-related quality-of-life with a maximum of 1900 points, which signifies highest quality of function. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery |
| Change in EQ5D questionnaire | The EQ-5D (EuroQuol 5 Dimension scale) questionnaire is a widely used patient-related outcome measurement for quality of life assessment in general, consisting of 25 dichotomous questions from five parameters and a visual analog scale to plot perceived health. A persons selfperceived health status is then evaluated as a 5-digit number, ranging from 11111 (having no problems) to 33333 (having problems in all 5 aspects), and as a number from 0 (worst imaginable health) to 100 (best imaginable health). | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery |
| Change in Numeric Ranking Scale | Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery |
| Complications | Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant. | The outcome is registered 2 years after surgery |
| Change in humeral tuberosities | Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |