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Total elbow arthroplasty provides superior outcomes for humeral fractures in the elderly
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May 2013
Total elbow arthroplasty provides superior outcomes for humeral fractures in the elderly
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A
A multicenter, prospective, randomized, controlled trial of open reduction-internal fixation versus total elbow arthroplasty for displaced intra-articular distal humeral fractures in elderly patients
J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):3-12. Epub 2008 Sep 26Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
42 elderly patients with displaced intra-articular, distal humeral fractures were managed using open reduction and internal fixation (ORIF) or with total elbow arthroplasty (TEA). Assessment 2 years post-operatively supported the use of TEA in this elderly population. MEPS scores were significantly better in the TEA group, while DASH sores were superior during early follow-ups. These findings were accompanied by a trend towards a reduction in complications in the TEA group.
Publication Funding Details
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Funding:
Industry funded
Sponsor:
Orthopaedic Trauma Association and Zimmer (Warsaw, IN)
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Randomization
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Currently, the gold standard of treatment for displaced intra-articular, distal humeral fractures in young patients is open reduction and internal fixation (ORIF). The use of ORIF in the elderly is associated with less predictable outcomes, increasing the number of complications. Total elbow arthroplasty is an established treatment option for revision of internal fixation and may provide superior outcomes, if used as a primary treatment in this elderly population.
What was the principal research question?
Did open reduction and internal fixation or total elbow arthroplasty provide the best clinical and functional outcomes for elderly patients with displaced intra-articular, distal humeral fractures, when measured over a 2 year period?
Study Characteristics
-
Population:
42 patients with displaced intra-articular distal humeral fractures
Intervention:
ORIF Group: Patients had their distal humeral fractures treated with open reduction-internal fixation (ORIF) (n=21).
Comparison:
TEA Group: Patients had their distal humeral fractures treated with total elbow arthroplasty (TEA) (n=21).
Outcomes:
Outcome measures included the Mayo Elbow Performance Score (MEPS), Disability of the Arm Shoulder and Hand (DASH) score, and the incidence of complications and treatment requiring re-operation
Methods:
RCT: multi center; prospective; double blinded (patients and outcome assessors)
Time:
2 years (6 week 3, 6, 12, 24 month follow-up)
What were the important findings?
- Intra-operative conversion between groups resulted in 16 patients receiving ORIF and 26 patients receiving TEA; 5 patient randomized to ORIF received TEA due to severe fracture comminution.
- The mean operative time was significantly shorter for the TEA group (108 +/- 21 minutes) in comparison to the ORIF group (140 +/- 38 minutes) (p=0.001).
- The mean duration of hospitalization was shorter for the TEA group (7.7 +/- 6.3 days), compared to the ORIF group (9.3 +/- 9.7 days), but this difference did not reach statistical significance (p=0.5).
- Patients who underwent TEA had significantly better MEPS scores at 3 , 6, 12, and 24 month follow-up (p=0.01, p=0.003, p=0.01, p=0.015, respectively).
- DASH scores at 6 week and 6 month follow-up assessments were significantly better in the TEA group (6 weeks: 43; 6 months: 31), compared to the ORIF group (6 weeks: 77; 6 months: 47) (6 weeks: p=0.02; 6 months: p=0.04)
- Re-operation rates were not significantly different between the ORIF group (27%, 4/15 patients) and TEA group (12%, 3/25 patients) (p=0.2)
What should I remember most?
Total elbow arthroplasty resulted in significantly better MEPS at two years and provided superior DASH scores during early follow-up assessments, in comparison to those who received open reduction-internal fixation. These positive results were also accompanied by a trend towards fewer revision surgeries.
How will this affect the care of my patients?
Total elbow arthroplasty is a preferable treatment option for elderly patients with displaced intra-articular, distal humeral fractures, providing superior clinical and functional outcomes.
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