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Study: Clinical improvements maintained, improved at 5 years with iFuse implant

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SAN FRANCISCO — Favorable 5-year clinical and radiographic outcomes for the iFuse Implant System, a minimally invasive surgical device indicated for fusion for certain disorders of the sacroiliac joint, were reported here by the manufacturer during the North American Spine Society Annual Meeting.

Clinical improvements observed at 12 months were maintained or improved at 5 years, including low back pain relief, function and patient satisfaction for patients treated with iFuse, according to a SI-BONE press release.

The results, which were published in the Open Orthopaedics Journal, supported long-term durability of positive clinical outcomes of patients treated for degenerative sacroiliitis or sacroiliac joint (SI) joint disruptions with minimally invasive surgical SI joint fusion using a series of triangular titanium plasma spray coated implants, according to the release.

Twenty-one consecutive patients participated in the single-center study, among whom 17 provided clinical information and 15 underwent X-ray and CT imaging at 5 years.

At 5 years, the clinical improvements observed at 12 months were maintained or had further improved, including in patient satisfaction (82%). Pain level improved from 8.3 at baseline to 3.4 at 12 months to 2.4 at 5 years (0 = no pain, 10 = worst pain imaginable), and the ability to perform light, moderate and vigorous activities showed continual improvement from 12 months to 5 years. Mean Oswestry Disability Index score was measured at 5 years only and was 21.5, indicating minimal to moderate disability, according to the release.

“There are well over a dozen peer-reviewed publications now that demonstrate safety and effectiveness of the iFuse implant system,” Gunnar B.J. Andersson, MD, PhD, president of the International Society for the Advancement of Spine Surgery, said in the release. “This most recent publication reporting 5-year results provides further clinical evidence that this minimally invasive surgical technique is safe and effective and provides lasting relief for patients who suffer from certain SI joint disorders.”

Reference: Rudolf L. Open Orthop J. 2014;doi:10.2174/1874325001408010375.

Disclosure: Andersson has no relevant financial disclosures.