Artikel
Minimally invasive fusion of the sacroiliac joint using transarticular implants compared to conservative management – 1 year follow-up results of a prospective randomized controlled multicenter trial
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Autoren
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Julius Dengler
- Klinik für Neurochirurgie, Charité - Universitätsmedizin Berlin, Germany
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Robert Pflugmacher
- Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn, Germany
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Bengt Sturesson
- Department of Orthopedics, Ängelholm Hospital, Ängelholm, Sweden
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Eddie van Eeckhoven
- SI-BONE, Department of Research and Development, Milano, Italy
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Peter Vajkoczy
- Klinik für Neurochirurgie, Charité - Universitätsmedizin Berlin, Germany
| Veröffentlicht: | 8. Juni 2016 |
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Gliederung
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Objective: Increasing patient age is one of the main risk factors for sacroiliac joint (SIJ) pain, which can result in disability and reduced quality of life. Conservative treatment usually fails in elderly patients. Minimally invasive surgical SIJ fusion may be an attractive alternative for this age group of patients. We are currently conducting an international trial that aims to compare the long-term results of minimally invasive transarticular SIJ fusion with those of conservative management.
Method: During the now completed 2 year recruitment phase 109 patients were included into this prospective, randomized, controlled trial at 9 study centers. The patients were assigned to either structured conservative management (n=55) or a minimally invasive transarticular SIJ fusion using triangular, rod-shaped titanium implants with porous coating (n=54). The primariy endpoint is the description of symptoms by visual analogue scale (VAS) and Oswestry disability index (ODI) at 6 months of follow-up. So far, the 3 months follow-up is completed and the 1 year results would be available for presentation at the DGNC meeting in June of 2016.
Results: Mean patient age was 48.0 years and 74% of patients were female. All patients had undergone SIJ injections prior to inclusion and 33% surgical lumbar spine fusion. At baseline, mean VAS was 74.5 and mean ODI 56.3%. In the surgical treatment group, the mean duration of surgery was 55.5 minutes and the mean stay in hospital was 3.7 days. At 3 months of follow-up, we observed a decrease of 42.6 points on the VAS in the surgical treatment group compared to a decrease of 5.6 points in the conservative management group (p<0.01). There was a reduction in ODI of 16.6% in the surgical treatment group and of 4.6% in the conservative management group (p<0.01). There were no intraoperative complications. In 1 of 54 surgical cases (1.9%) we found a malpositioning of 1 of the implants, which did not require surgical revision.
Conclusions: The current results of our trial suggest that minimally invasive transarticular SIJ fusion may be a safe treatment alternative to conservative management of SIJ pain and may also lead to a more effective pain reduction. If these effects will last during the course of this trial, minimally invasive transarticular SIJ fusion may also be attractive for treating SIJ pain in elderly patients.
