broken shoulder subcapital humerus fracture
Conditions
Interventions
None listed
Sponsors
OLVG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with subcapital humerus fractures treated non-operatively are eligible for the study. A subcapital humerus fracture is defined as a two-part surgical neck fracture, regardless of the degree of fragment displacement. Non-operative treatment includes sling immobilization followed by gradual mobilization. The study will evaluate the results of adults and older adults. The adult cohort encompasses patients between 18 and 65 years of age. The older adult cohort encompasses patients of at least 65 years of age. Adults (18- 65 years of age): Patients with subcapital humerus fractures treated non-operatively and minimum follow up length of 2 years will be included. In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Men or women of between 18 and 65 years of age upon the first presentation at the Emergency Department. 2. Written informed consent to participate in the study Older adults (at least 65 years of age): Patients with a subcapital humerus fracture treated non-operatively and a minimum follow up length of 2 year will be included. In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Men or women of at least 65 years of age upon the first presentation at the Emergency Department. 2. Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Adults (18- 65 years of age): A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Patients less than 2 years of follow up time (the mean time for bone consolidation is 2 years) 2. Patients presented to the emergency department more than 1 month after injury (a delay in adequate treatment may affect functional shoulder outcomes) 3. Patients with an open fracture 4. Patients with neurovascular injury 5. Patient with concomitant injuries of the affected shoulder 6. Incapacitated patients 7. Patients with a shoulder arthroplasty in the contralateral shoulder 8. Patients with a nerve injury and concomitant motor function impairment of the contralateral shoulder 9. Patients with a medical history of a proximal humerus or clavicle fracture in the contralateral shoulder 10. patients with a severely decreased shoulder function due to any other medical condition of the contralateral shoulder at the time of the outpatient visit Older adults (at least 65 years of age): A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Patients less than 2 years of follow up time (the mean time for bone consolidation is 2 years) 2. Patients presented to the emergency department more than 1 month after injury (a delay in adequate treatment may affect functional shoulder outcomes) 3. Patients with an open fracture 4. Patients with neurovascular injury 5. Patients with concomitant injuries of the affected shoulder 6. Incapacitated patients 7. Patients with a shoulder arthroplasty in the contralateral shoulder 8. Patients with a nerve injury and concomitant motor function impairment of the contralateral shoulder 9. Patients with a medical history of a proximal humerus or clavicle fracture in the contralateral shoulder 10. patients with a severely decreased shoulder function due to any other medical condition of the contralateral shoulder at the time of the outpatient visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: the Constant Murley Score. The CMS is a score ranging from 0 to 100 to evaluate the function of both shoulders. A higher score represents a better shoulder function. The CMS consists of four domains: pain (0-15), activities in daily living (0-10), mobility (0-50) and strength (0-25). To determine mobility the pain-free range of shoulder abduction, forward flexion, external rotation and internal rotation is tested. The shoulder strength is measured at 90 degrees in abduction. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes will be reported for adults and older adults: • Radiographic outcome: each X-ray image will be assessed by the radiologist for osteoarthritis, non-union (defined as the absence of consolidation 3 months after the initial trauma), fracture consolidation and avascular necrosis. Additionally, the humeral neck- shaft angle will be measured with the shoulder in external rotation. • Complications: the need for surgical intervention due to failure of non-operative management, nerve injury, chronic pain syndrome, rotator cuff pathology, mal-union (defined as healing of the bone in an abnormal position), non-union and mortality after 1 year. • The quality of life measured with the EuroQol5D (EQ5D) questionnaire. • The sleep quality reflected by the Pittsburgh Sleep Quality Index (PSQI) • The rate of the shoulder as a percentage of normal shoulder function measured with the Single Assessment Numeric Evaluation (SANE). • The performance of daily activities measured with the Disabilities of the Arm, Shoulder and Hand score (DASH) questionnaire. Two additional secondary outcomes will be reported for adults (18-65 years). • Return to sports measured with the DASH score module sports. • Return to work using the DASH score module work. Two additional secondary outcomes will be reported for older adults (18-65 years). • The functional independency reflected measured with the Katz index. • The ambulation ability of patients measured with the Functional Ambulation Categories (FAC). | — |
Countries
Netherlands
Outcome results
None listed