Clavicle, Fracture
Conditions
Keywords
clavicle fractures, midshaft, dislocated, operative treatment, conservative treatment, non-operative treatment, randomized controlled trial, bone plates
Brief summary
The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.
Detailed description
Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity. There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.
Interventions
PROCEDUREOperative treatment
Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.
PROCEDURENon-operative treatment with arm immobilised to a sling
Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* a completely displaced middle third clavicle fracture, no cortical contact between main fragments * fresh fracture, treatment within seven days after injury * age between 18 and 70 years * provided informed consent
Exclusion criteria
* fracture was not dislocated * multiple injured patient * associated neurovascular injury, or suspicion of it * reduced cooperation * cancer or any severe illness impairing health * pathological fracture * treatment seven days after injury * open fracture * corticosteroid or immunosuppressive medication * upper extremity fracture at same time * an earlier clavicle or shoulder region fracture * pregnancy * lack of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder function | Three months | Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest and activity | Three weeks | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly. |
| Fracture healing | Three months | Fracture healing is examined from Xray. |
| Disability of the Arm, Shoulder and Hand (DASH) | Three months | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. |
| Disabilities of the Arm, Shoulder and Hand (DASH) | Two years | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. |
| Pain at rest and at activity | Three months | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly |
| Complications | Continous till two years | Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation. |
Countries
Finland
Outcome results
None listed