An observational study in Elbow Fracture and Elbow Arthropathy, sponsored by Diakoniekrankenhaus Friederikenstift. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-05.
Sponsored by Diakoniekrankenhaus Friederikenstift · 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.
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.
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.
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).
Minimum age: 18 years Sex: All
Inclusion Criteria:
Exclusion Criteria:
All patients who received TEA for an acute trauma with fracture of the distal humerus.
Procedure: Total elbow arthroplasty
All patients who received TEA due to a failed reconstruction or non-operative treatment after a distal humerus fracture.
Procedure: Total elbow arthroplasty
Implantation of a total elbow arthroplasty after distal humerus fracture
Range of motion
Measurement of the range of motion for extension/flexion
Time frame: minimum follow-up: 6 months
Mayo Elbow Performance Score
Objective score evaluation the function of the elbow
Time frame: minimum follow-up: 6 months
Complication
appearance of a complication
Time frame: minimum follow-up: 6 months
DASH score
Disabilities of the Arm, Shoulder and Hand: subjective score evaluation the function
Time frame: minimum follow-up: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Diakoniekrankenhaus Friederikenstift