Artikel
2-year results from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. conservative management for chronic low back pain originating from the sacroiliac joint
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Autoren
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Julius Dengler
- Charité - Universitätsmedizin Berlin, Klinik für Neurochirurgie, Berlin, Deutschland
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Djaya Kools
- Onze-Lieve-Vrouw Hospital, Department of Neurosurgery, Aalst, Belgien
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Robert Pflugmacher
- Universitätsklinikum Bonn, Klinik für Orthopädie und Unfallchirurgie, Bonn, Deutschland
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Alessandro Gasbarrini
- Instituto Ortopedico Rizzoli di Bologna, Chirurgia Vertebrale, Bologna, Italien
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Domenico Prestamburgo
- Ospedale di Legnano, Department of Orthopedics and Traumatology, Legnano, Italien
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Paolo Gaetani
- Policlinico S. Matteo, Department of Neurosurgery, Pavia, Italien
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Daniel Cher
- SI-BONE, Clinical Affairs, San José, CA, Vereinigte Staaten
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Eddie van Eeckhoven
- Eeckhoven bvba, Kontich, Belgien
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Marten Annertz
- Skane University Hospital, Department of Radiology, Lund, Schweden
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Bengt Sturesson
- Ängelholm Hospital, Department of Orthopedics, Ängelholm, Schweden
| Veröffentlicht: | 18. Juni 2018 |
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Gliederung
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Objective: In 15-30% of patients with chronic LBP, a significant proportion of pain originates from the sacroiliac joint (SIJ). The SIJ is also implicated in up to 40% of patients with pain after lumbar fusion surgery. Conservative management (CM) of SIJ pain is challenging and long-term results are poor. Over recent years, minimally-invasive SIJ fusion (SIJF) was introduced as a potential alternative to CM. We compared the safety and effectiveness of SIJF with triangular titanium implants (TTI) vs. CM in patients with chronic SIJ pain.
Methods: In this prospective, multicenter randomized controlled trial, we included 103 subjects with chronic SIJ pain between June 2013 and May 2015. Patients were assigned to either CM (n=51) or SIJF (n=52) with TTI. Endpoints included self-rated LBP, leg pain, back dysfunction (Oswestry Disability Index, ODI), quality of life, depression symptoms, and SIJ function with active straight leg raise test.
Results: At 2 years of follow-up, mean LBP improved by 45 points in the SIJF group and 11 points in the CM group (difference of 30.4 points, p<.0001). Mean ODI improved by 26 points in the SIJF group and 8 points in the CM group (difference of 18 points, p<.0001). Parallel improvements were seen in leg pain, quality of life measures and SIJ function. In the SIJF group, the proportion of subjects with opioid use decreased from 55.0% at baseline to 33.3% at 24 months (p<0.01), with no significant change in the CM group (47.1% and 45.7%). Subjects in the CM group that crossed over to surgery after 6 months showed improvements in all measures similar to those originally assigned to SIJF. One case of postoperative nerve impingement occurred in the surgical group. Two SIJF subjects had recurrent pain attributed to possible device loosening and 1 had postoperative hematoma. CT scans, performed in 50/52 (96%) of subjects assigned to SIJF, provided information on 35 right and 31 left sides with a total of 198 implants. There was no evidence of implant breakage or device migration. Breaches occurred in 17 of 198 (8.6%) implants, including 7 breaches into the sacral foramen, 3 anteriorly and 8 posteriorly.
Conclusion: For patients with chronic SIJ pain, minimally invasive SIJF with TTI was safe and more effective throughout 2 years in improving pain, disability, quality of life and leg function compared to CM. Our findings suggest that SIJF with TTI may be viewed as a relevant treatment alternative in patients failing CM of SIJ pain.
