The primary objective is to assess functional shoulder outcome scores and complications after non-operative treatment of subcapital humerus fractures among adults and older adults at least 2 years after the fracture. The secondary objectives are: 1…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Worldwide 6% of all fractures are localized in the proximal humerus and the
incidence rate is expected to increase. Proximal humerus fractures (PHF) are
strongly associated with osteoporosis and are most frequently observed in the
geriatric population, showing a peak incidence of 379 per 100.000 among females
above 80 years of age. The mortality rate is 10% and it is considered as one of
the major causes for social dependency among older adults. The most common
causes of PHF in patients younger than 50 years of age are high-energy traumas
and sports related injuries. PHF could have a high impact on daily life
activities: patients may be unable to do sports or carry out their work.
Treatment options include surgical intervention or non-operative management,
depending on the type of fracture, fragment displacement and patient
characteristics. Twenty percent of the cases require surgical intervention.
However, a lack of consensus exists on correct indications. Thirteen percent of
proximal humerus fractures are subcapital humerus fractures which are most
frequently treated non-operatively. Previous studies have reported the outcomes
of different surgical techniques, patients sustaining three- or four-part
fractures and populations including patients of all ages. However, little is
known about outcomes after non-operative treatment of subcapital humerus
fractures and few studies have reported a follow-up time of 2 years or longer.
It is hypothesized that non-operative treatment of subcapital humerus fractures
are associated with good functional outcome scores and a low complication rate.
In case satisfactory outcomes are reported surgical costs and intra- and
postoperative complications could be prevented.
Study objective
The primary objective is to assess functional shoulder outcome scores and
complications after non-operative treatment of subcapital humerus fractures
among adults and older adults at least 2 years after the fracture. The
secondary objectives are:
1. To assess which factors (e.g. age, comorbidities, ambulation ability,
independency in activities of daily living, trauma mechanism) are associated
with a difference of more than 10 points between the Constant Murley Score
(CMS) of the affected and contralateral shoulder in patients with a subcapital
humerus fracture treated non-operatively.
2. To describe the number of patients with a subcapital humerus fracture
treated surgically and non-operatively.
It is hypothesized that the difference between the CMS of the affected shoulder
and contralateral shoulder is less than 10 points.
Study design
A cross-sectional cohort study will be carried out at OLVG Hospital Amsterdam
in the Netherlands.
Study burden and risks
No costs are associated with participation in the study. Costs associated with
the radiographs will be covered and participants will be compensated for travel
expenses (including parking fees). Participation requires physical efforts: the
trip to the hospital, obtaining radiographs, undergoing a shoulder examination
and the completion of the questionnaires. The duration of the shoulder
examination will be 15 minutes, completing the questionnaires 25 minutes and
having the radiographs taken 10 minutes. A potential risk associated with the
study is radiation dosage applied in radiography. However, the dosage radiating
from the X-ray source is very low and may not cause any adverse health effects:
the radiation dosage of two radiographs is 0.08 mSv. As illustration, the
annual background radiation in the Netherlands is ~2.5 mSv. There are no
benefits for participating patients. Nevertheless, patients may appreciate
having the shoulder examined and checked with additional radiographs.
Participation will contribute to increase current knowledge and improve
treatment for patients with subcapital humerus fractures.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71324.100.19 |