Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management

被引:59
|
作者
Sturesson, Bengt [1 ]
Kools, Djaya [2 ]
Pflugmacher, Robert [3 ]
Gasbarrini, Alessandro [4 ]
Prestamburgo, Domenico [5 ]
Dengler, Julius [6 ]
机构
[1] Angelholm Hosp, Dept Orthoped, Aleris, Angelholm, Sweden
[2] Onze Lieve Vrouw Hosp Aalst, Dept Neurosurg, Aalst, Belgium
[3] Univ Hosp Bonn, Dept Orthoped & Traumatol, Bonn, Germany
[4] Inst Ortoped Rizzoli Bologna, Bologna, Italy
[5] Osped Legnano, Dept Orthoped & Traumatol, ASST Ovest Milanese, Legnano, Italy
[6] Charite, Dept Neurosurg, Berlin, Germany
关键词
Sacroiliac joint dysfunction; Pelvic girdle pain; Sacroiliac joint fusion; Titanium sacroiliac implant; Randomized controlled trial; Conservative management; iFuse Implant System; CLINICALLY IMPORTANT DIFFERENCE; LOW-BACK-PAIN; SACROILIAC JOINT; LUMBAR; ARTHRODESIS; DISABILITY; DIAGNOSIS; SURGERY;
D O I
10.1007/s00586-016-4599-9
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
To compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain. 103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (N = 52) or CM (N = 51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025. At 6 months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, p < 0.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (p < 0.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group. In patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life.
引用
收藏
页码:708 / 719
页数:12
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