A Phase 2/3 interventional study of Operative treatment and Non-operative treatment with arm immobilised to a sling in Clavicle and Fracture, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-09-13.
Sponsored by Helsinki University Central Hospital · Phase 2/3, Interventional, and Treatment
The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 60 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-operative (conservative) treatment of the clavicle fracture
Procedure: Non-operative treatment with arm immobilised to a sling
Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.
Procedure: Operative 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.
Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
Shoulder function
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.
Time frame: Three months
Shoulder function
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.
Time frame: One year
Shoulder function
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.
Time frame: Two years
Disability of the Arm, Shoulder and Hand (DASH)
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.
Time frame: Three months
Pain at rest and activity
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.
Time frame: Three weeks
Fracture healing
Fracture healing is examined from Xray.
Time frame: Three months
Complications
Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.
Time frame: Continous till two years
Disability of the Arm, Shoulder and Hand (DASH)
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.
Time frame: One year
Disabilities of the Arm, Shoulder and Hand (DASH)
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.
Time frame: Two years
Pain at rest and activity
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.
Time frame: Six weeks
Pain at rest and at activity
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
Time frame: Three months
Pain at rest and at activity
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
Time frame: One year
Pain at rest and at activity
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
Time frame: Two years
Fracture healing
Fracture healing is examined from Xray.
Time frame: One year
Fracture healing
Fracture healing is examined from Xray.
Time frame: Two years
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital