Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?
1 other identifier
observational
23
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
September 30, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedOctober 5, 2017
October 1, 2017
3.2 years
September 30, 2017
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Range of motion
Measurement of the range of motion for extension/flexion
minimum follow-up: 6 months
Mayo Elbow Performance Score
Objective score evaluation the function of the elbow
minimum follow-up: 6 months
Secondary Outcomes (1)
Complication
minimum follow-up: 6 months
Other Outcomes (1)
DASH score
minimum follow-up: 6 months
Study Arms (2)
Primary arthroplasty
All patients who received TEA for an acute trauma with fracture of the distal humerus.
Secondary arthroplasty
All patients who received TEA due to a failed reconstruction or non-operative treatment after a distal humerus fracture.
Interventions
Implantation of a total elbow arthroplasty after distal humerus fracture
Eligibility Criteria
Out of 35 patients, who fit the inclusion criteria, six had died from unrelated causes. 23 patients participated in the study, since six patients were lost to follow-up. Nine of the 23 patients (mean age: 70 years; 8 women) had implantation of a primary TEA. The remaining 14 patients (mean age: 63 years; 11 women) received secondary implantation of a TEA. The secondary TEA was implanted after an implant failure in four patients, twice because of a non-union (one after reconstruction and one after non-operative therapy), and in three patients because of a non-union with an additional partial necrosis of the distal humerus. Two patients received secondary TEA because of a posttraumatic arthritis after internal fixation and three times because of a posttraumatic arthritis after non-operative treatment. The mean follow-up was 28 months (range: 6 - 73) with a mean age of 66 years (range: 41 - 85).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Physician
Study Record Dates
First Submitted
September 30, 2017
First Posted
October 5, 2017
Study Start
January 21, 2013
Primary Completion
March 31, 2016
Study Completion
March 31, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share