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Risedronate following total hip arthroplasty does not prevent periprosthetic bone loss
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January 2016
Risedronate following total hip arthroplasty does not prevent periprosthetic bone loss
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A
No effect of risedronate on femoral periprosthetic bone loss following total hip arthroplasty
Acta Orthop. 2015 Oct;86(5):569-74Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
74 patients scheduled for uncemented total hip arthroplasty were randomized to postoperative administration of either risedronate or placebo for 6 months. The purpose of this study was to compare changes in periprosthetic bone mineral density between groups at 4 year follow-up. Additionally, component migration, the incidence of heterotopic ossification, and clinical outcomes were assessed during follow-up. Results demonstrated no significant difference in periprosthetic BMD changes between groups after 4 years.
Publication Funding Details
+
Funding:
Not Reported
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.
1/4
Randomization
4/4
Outcome Measurements
0/4
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?
Periprosthetic bone mass loss following total hip arthroplasty remains an important concern, given its implications in possible periprosthetic fracture and component loosening. Much research has been conducted on the efficacy of risedronate, a bisphosphonate, in the attenuation of bone loss in patients with osteoporosis, and research has started to be conducted in its possible role as a postoperative therapy following total joint arthroplasty. Nevertheless, the body of evidence is still too small to establish the role of risedronate therapy following total hip arthroplasty.
What was the principal research question?
Following total hip arthroplasty, what effect does risedronate therapy have on periprosthetic bone resorption, as compared to placebo over 4 year follow-up?
Study Characteristics
-
Population:
73 patients (40-70 years old) with hip osteoarthritis and scheduled for uncemented total hip arthroplasty. Oral supplements of calcium carbonate (1000mg/day) and vitamin D (400IU/day) were given to all patients for 6 months following surgery (n=61 completed follow-up)
Intervention:
Risedronate group: After surgery, participants were prescribed 35mg tablets of risedronate to be taken once per week for 6 months. (n=30; Mean age: 62 +/- 5)
Comparison:
Placebo group: After surgery, participants were prescribed placebo tablets to be taken once per week for 6 months. (n=31; Mean age: 60 +/- 5)
Outcomes:
Primary outcome was periprosthetic bone mineral density (BMD), assessed in Gruen Zone 1-7 via dual X-ray absorptiometry. Vertebral BMD was also assessed. Radiographic analysis was also performed to evaluate femoral stem migration (EBRA femoral component analysis software), as well as the incidence of heterotopic ossification. Clinical outcome measures included the Harris Hip Score and the EuroQoL-5D questionnaire.
Methods:
RCT; double-blind, placebo-controlled; single-center
Time:
Follow-up performed at 4 years.
What were the important findings?
- Mean decrease in BMD of Gruen zones 1 and 7 after 4 years did not significantly differ between groups. In Gruen zone 1, the mean decrease in BMD was -19% (+/-14) in the risedronate group and -21% (+/-13) in the placebo group (p=1.0). In Gruen zone 7, decreases were -23% (+/-16) and -22% (+/-15%), respectively (p=1.0).
- There were also no significant between-group differences in percent change in BMD of Gruen zones 2-6 after 4 years (all p>0.05).
- Groups demonstrated a similar degree of subsidence of the femoral stem after 4 years; -1.7mm (+/-1.2) in the risedronate group and -1.7mm (+/-1.5) in the placebo group.
- Incidence of heterotopic ossification was similar between groups; 10 patients of the risedronate group (8 Class I-II; 2 Class III-IV) and 8 patients in the placebo group (7 Class I-II; 1 Class III-IV).
- Clinical outcome measures of the Harris Hip Score and EQ-5D were similar between groups at 4-year follow-up.
What should I remember most?
Postoperative administration of risedronate for 6 months after total hip arthroplasty was not met with a significant effect on perioprosthetic bone mineral density at 4-year follow-up, as compared to placebo.
How will this affect the care of my patients?
The results of this study suggest that risedronate is not effective for long-term attenuation of periprosthetic bone mineral density following total hip arthroplasty. Additional, high-quality randomized controlled trials are needed to confirm the current findings, and evaluate if there is role of risedronate in the postoperative management of patients following total hip arthroplasty.
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