Aims Post-operative migration of cemented acetabular components as measured by radiostereometric analysis (RSA) has a strong predictive power for late, aseptic loosening. Also, radiolucent lines predict late loosening. Migration has been reduced by systemic bisphosphonate treatment in randomised trials of hip and knee arthroplasty. Used as a local treatment, a higher local dose of bisphosphonate can be achieved without systemic exposure. We wished to see if this principle could be applied usefully in total hip arthroplasty (THA).
Patients and Methods In this randomised placebo-controlled, double-blinded trial with 60 participants, we compressed gauze soaked in bisphosphonate solution (ibandronate) or saline against the acetabular bone bed immediately before cementing the acetabular component. RSA, classification of radiolucent lines, the Harris Hip Score (HHS) and the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) were carried out at three-, six-, 12-, and 24-month follow-up.
Results Migration of the cemented acetabular component relative to the pelvis was reduced by movement almost half in the ibandronate group, when measured as maximum total point or as movement of the femoral head (p = 0.001 and 0.004, respectively). Radiolucent lines after one year were classified as absent, partial or complete, and correlated with treatment (rho 0.37; p = 0.004). Only three of 30 patients in the ibandronate group had complete lines, compared with 13 of 28 in the placebo group (p = 0.002). There were no significant effects on HHS or WOMAC score.
Conclusion Considering the power of RSA to predict loosening of cemented acetabular components, and the likelihood that radiolucent lines indicate risk of loosening, these data suggest that local treatment with a bisphosphonate can reduce the risk of late aseptic loosening.
Cite this article: Bone Joint J 2017;99-B:317–24.
J. Schilcher: Study design, Study conduct, Data collection, Data analysis, Data interpretation, Drafting manuscript, Revising manuscript content, Approving final version of manuscript, Responsibility for the integrity of the data analysis.
L. Palm: Study design, Study conduct, Data collection, Data interpretation, Revising manuscript content, Approving final version of manuscript.
I. Ivarsson: Study design, Study conduct, Data collection, Data interpretation, Revising manuscript content, Approving final version of manuscript.
P. Aspenberg: Study design, Data analysis, Data interpretation, Drafting manuscript, Revising manuscript content, Approving final version of manuscript, Responsibility for the integrity of the data analysis.
The authors declare that grants were received by their institution to complete the study from the Östergötland County Council and the Swedish Research Council.
P. Aspenberg holds shares in AddBIO, a company trying to commercialise a method for bisphosphonate coating of implants to be inserted in bone, and holding a patent for this method.
Although none of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article, benefits have been or will be received but will be directed solely to a research fund, foundation, educational institution, or other non- profit organization with which one or more of the authors are associated.
This article was primary edited by G. Scott.
- Received June 3, 2016.
- Accepted October 6, 2016.
- ©2017 The British Editorial Society of Bone & Joint Surgery