Elbow Fracture Clinical Trial
Verified date | October 2017 |
Source | Diakoniekrankenhaus Friederikenstift |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Total elbow arthroplasty (TEA) results in immediate pain release with good functional results after distal humerus fractures. But still open reduction and internal fixation is recommended as treatment of choise due to a lifelong loading limitiation, unknown implant survival and problematic revision surgery after TEA. The purpose of this study was to compare functional results and complication rates after primary total elbow arthroplasty (TEA) and TEA after failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal humerus fractures. We hypothesised that clinical and functional results are better for primary TEA with less complications.
Status | Completed |
Enrollment | 23 |
Est. completion date | March 31, 2017 |
Est. primary completion date | March 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Minimum age: 18 years Sex: All Inclusion Criteria: - Total elbow arthroplasty for an acute trauma with fracture due to an acute trauma - Total elbow arthroplasty due to failed reconstruction after distal humerus fracture - Total elbow arthroplasty after non-operatic treatment after distal humerus fracture Exclusion Criteria: - previous injury at the fractured elbow - neuro-muscular disease - cortisone or other immune suppressive therapy - open fracture grade II or higher according to Tscherne and Ostern |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Diakoniekrankenhaus Friederikenstift |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | DASH score | Disabilities of the Arm, Shoulder and Hand: subjective score evaluation the function | minimum follow-up: 6 months | |
Primary | Range of motion | Measurement of the range of motion for extension/flexion | minimum follow-up: 6 months | |
Primary | Mayo Elbow Performance Score | Objective score evaluation the function of the elbow | minimum follow-up: 6 months | |
Secondary | Complication | appearance of a complication | minimum follow-up: 6 months |
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