Clinical Data

37 Patients, Interpositional Allografts Revised with iFuse 3D (Kranenburg - MDER 2022)

Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series

Kranenburg A, Garcia-Diaz G, Cook JH, Thambuswamy M, James W, Stevens D, Bruggeman A, Chen Y, Capobianco R, Reckling WC, Siegal JD.
Med Devices (Auckl). 2022 Jul 20;15:229-239.
DOI: 10.2147/MDER.S369808. PMID: 35899066; PMCID: PMC9309279.


Background: Distraction arthrodesis (DA) and stabilization of the sacroiliac (SI) joint by placing standalone structural allograft (SA) into the joint from a posterior trajectory has recently been introduced as a surgical procedure for chronic SI joint pain refractory to non-operative care.

Retrospective case series of patients with recurrent and/or persistent pain after placement of one or more interpositional/intraarticular standalone SAs between the ilium and sacrum using a posterior procedure to treat SI joint pain/dysfunction. Patients subsequently underwent surgical revision with porous titanium fusion implants using a lateral transfixing procedure. The demographic, clinical, and radiographic features of these cases are described.

Results: Data were available for 37 patients. The average (SD) age was 57 (13) years, 62% were female, and the average BMI was 31 (5.4). On average, two SA implants were placed per joint; 46% of cases were bilateral. At follow-up, two common themes were identified: lucencies around the implants and suboptimal implant position. None of the cases showed radiographic fusion of the SI joint prior to revision. One patient had an inflammatory reaction to the SA. All patients presented for revision due to either continued (49%) or recurrence (51%) of pain. In one revision case, the SA was forced ventrally, resulting in a sacral fracture, which was treated conservatively without sequelae.

Conclusions: The popularity of standalone SA for SI joint stabilization/fusion with a posterior procedure is increasing. This case series demonstrates that clinical failures from this procedure may require surgical revision. The proposed fusion strategy (DA) for these products is unproven in the SI joint, and, therefore, properly conducted prospective randomized clinical trials with long-term clinical and radiographic follow-up are important to establish the safety and efficacy of this approach. In the meantime, the placement of lateral titanium implants appears to be an effective revision strategy.

Keywords: distraction arthrodesis, structural allograft, sacroiliac joint, sacroiliac joint fusion, ligamentotaxis

Author Information

  • Kranenburg A - Southern Oregon Orthopedics, Medford, OR, USA.
  • Garcia-Diaz G - OrthoSpine Advance Health, Inc, Merced, CA, USA.
  • Cook JH - Central Texas Brain and Spine, Austin, TX, USA.
  • Thambuswamy M - Oklahoma Spine & Brain Institute, Tulsa, OK, USA.
  • James W - James Marco Health, Prescott, AZ, USA.
  • Stevens D - Utah Spine Specialists, Bountiful, UT, USA.
  • Bruggeman A - Texas Spine Care Center, San Antonio, TX, USA.
  • Chen Y - OrthoNeuro Inc, New Albany, OH, USA.
  • Capobianco R, Reckling WC - SI-BONE Inc, Santa Clara, CA, USA.
  • Siegal JD - Key Clinics LLC, Mayfield Heights, OH, USA.

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