Shoulder Fractures
Conditions
Keywords
Humeral Fractures, Proximal
Brief summary
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.
Interventions
DEVICEReverse Total Shoulder Arthroplasty
The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
DEVICEHemiarthroplasty
The shoulder hemiarthroplasty
Sponsors
Herlev and Gentofte Hospital
Signe Rosner Rasmussen
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution * Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older. * All patients, regardless of age, with an insufficient or irreparable rotator cuff
Exclusion criteria
* Brachial plexus palsy * Previous ipsilateral fracture of clavicula, scapula, or proximal humerus * Cognitive disabilities or substance abuse enabling rehabilitation and follow-up * Patients without a Danish civil registration number
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Constant score (CS) | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS) | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 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. |
| Change in EQ5D questionnaire | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 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). |
| Change in Oxford Shoulder Score (OSS) | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 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). |
| Complications | The outcome is registered 2 years after surgery | Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant. |
| Change in humeral tuberosities | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays. |
| Change in Numeric Ranking Scale | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain. |
Contacts
Primary ContactSigne R Rasmussen, MD
Outcome results
None listed