Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?
NCT ID: NCT03302533
Last Updated: 2017-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2013-01-21
2017-03-31
Brief Summary
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Detailed Description
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This retrospective study was performed at a level I trauma centre. All patients were informed about the study and provided written informed consent.
All patients undergoing total elbow arthroplasty (TEA) were identified by electronically screening our database by the OPS codes 5-824.4 (implantation of a linked TEA) and 5-824.5 (implantation of an unlinked TEA) between August 2008 and May 2014. Based on patient records and x-rays the indication for implantation of the TEA was retrospectively reviewed. All patients, who received a TEA for an acute trauma with fracture of the distal humerus (primary TEA) or due to a failed reconstruction or non-operative treatment after a distal humerus fracture (secondary TEA), were included in this study. A minimum follow-up of 6 months was set as inclusion criterion. Exclusion criteria were previous injury at the fractured elbow, neuro-muscular disease, cortisone or other immune suppressive therapy and open fracture grade II or higher according to Tscherne and Ostern.The patient records were reviewed for demographic and perioperative data. If the initial treatment was not conducted in our department, radiographs and patient records were requested. The follow-up examination included the evaluation of the range of motion and stability of the elbow, actual pain and satisfaction of the patient. To objectify the functional result the Mayo Elbow Performance Score (MEPS) and Disabilities of the Arm, Shoulder and Hand Score (DASH) were determined. Additionally, complications and revision surgeries were recorded. Complications were split up into minor (nerve irritation or postoperative haematoma) and major complications, which required a revision of the prosthesis. Periprosthetic fractures due to renewed fall with an adequate trauma were not counted as complication.
Perioperative data, the functional result (range of motion, MEPS, DASH) and postoperative complications were described for each group. Subsequently, these results were statistically compared using the Mann-Whitney U test as a two-way analysis of variance for independent factors. A p-value ≤ 0.05 was considered statistically significant. The statistical analysis was performed using SPSS for MAC (IBM SPSS Statistics 22, Chicago, Illinois).
We hypothesised that clinical and functional results are better for primary TEA with less complications.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Primary arthroplasty
All patients who received TEA for an acute trauma with fracture of the distal humerus.
Total elbow arthroplasty
Implantation of a total elbow arthroplasty after distal humerus fracture
Secondary arthroplasty
All patients who received TEA due to a failed reconstruction or non-operative treatment after a distal humerus fracture.
Total elbow arthroplasty
Implantation of a total elbow arthroplasty after distal humerus fracture
Interventions
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Total elbow arthroplasty
Implantation of a total elbow arthroplasty after distal humerus fracture
Eligibility Criteria
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Inclusion Criteria
* Total elbow arthroplasty due to failed reconstruction after distal humerus fracture
* Total elbow arthroplasty after non-operatic treatment after distal humerus fracture
Exclusion Criteria
* neuro-muscular disease
* cortisone or other immune suppressive therapy
* open fracture grade II or higher according to Tscherne and Ostern
18 Years
ALL
Yes
Sponsors
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Diakoniekrankenhaus Friederikenstift
OTHER
Responsible Party
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Dr. Alexander Ellwein
Assistant Physician
Other Identifiers
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001-2017
Identifier Type: -
Identifier Source: org_study_id