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Peer-reviewedCC BYMedical Devices: Evidence and Research

Navigating Porous Threaded Implants Across the SI Joint is Associated with a Lower Reported Rate of Symptomatic Acute Malposition

4 affiliations
  1. 1Neurosurgery
  2. 2Product Marketing
  3. 3Clinical, Regulatory and Quality
  4. 4Orthopedic Surgery

Abstract

Sharad Rajpal,1 Arjun Joshi,2 Daniel Cher,3 David W Polly41Neurosurgery, AdventHealth, Louisville, CO, USA; 2Product Marketing, SI-BONE, Inc., San Jose, CA, USA; 3Regulatory Affairs, SI-BONE, Inc., San Jose, CA, USA; 4Department of Orthopedics, University of Minnesota, Minneapolis, MN, USACorrespondence: Daniel Cher, Regulatory Affairs, SI-BONE, Inc., 88. W. Plumeria Drive, San Jose, CA, 95134, USA, Email [email protected]: To determine whether use of intraoperative navigation is associated with a reduced rate of acute symptomatic implant malposition during iliosacral implant placement in sacroiliac (SI) joint fusion and sacral fracture fixation.Methods: Retrospective analysis of post-market databases regarding device use and reported device-related complaints from a single device manufacturer between March 2021 and August 2026 were combined, including procedure type, procedure date and use of navigation systems. Analysis focused on lateral and posterolateral (PL) transiliac placement of a porous threaded implant (PTI, iFuse TORQ) during SI joint fusion and sacral fracture fixation procedures performed in the USA. All acute symptomatic implant malpositions reported as product complaints were identified and linked to index surgeries through manual identification. The proportion of navigated and non-navigated cases that resulted in symptomatic implant malposition was compared using Firth’s penalized logistic regression test.Results: 25,096 procedures using 68,352 PTI were identified. Navigation was used in 15.6% (n=3,919) of cases. Implant malposition causing acute symptoms occurred in 63 cases (overall rate 0.25%). Of these, 2 occurred in navigated cases (rate, 0.05%) and 61 occurred in non-navigated cases (rate, 0.29%, odds ratio 0.22, 95% CI 0.046– 0.639, p=0.0014).Conclusion: Navigation was associated with a markedly lower rate of acute symptomatic implant malposition during lateral or PL transiliac placement of a PTI.Plain Language Summary: Sacroiliac joint fusion is a widely accepted and performed procedures. Implant placement can be guided fluoroscopically or by navigation systems. Navigation systems are generally thought to allow more accurate implant placement.A manufacturer reviewed reported instances of acute symptomatic implant malposition in > 25,000 cases of SI joint fusion or pelvic fracture fixation surgeries using a porous threaded implant (iFuse TORQ, SI-BONE, Inc). Implant malposition occurred in 61 cases (rate of 0.29%) guided fluoroscopically and 2 cases (rate of 0.05%) guided with navigation systems (odds ratio 0.220, p=0.0014). The large rate difference is unlikely to be due to underreporting. These findings support the use of navigation during pelvic surgery to reduce symptomatic implant malposition.Keywords: porous threaded implants, sacroiliac joint arthrodesis, navigation, stereotactic surgery, implant malposition

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BibTeX
@article{rajpal2026navigating,
  title = {{Navigating Porous Threaded Implants Across the SI Joint is Associated with a Lower Reported Rate of Symptomatic Acute Malposition}},
  author = {Rajpal S and Joshi A and Cher D and Polly DW},
  journal = {Medical Devices: Evidence and Research},
  year = {2026},
  month = nov,
  url = {https://www.dovepress.com/navigating-porous-threaded-implants-across-the-si-joint-is-associated--peer-reviewed-fulltext-article-MDER},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Navigating Porous Threaded Implants Across the SI Joint is Associated with a Lower Reported Rate of Symptomatic Acute Malposition
AU  - Rajpal S
AU  - Joshi A
AU  - Cher D
AU  - Polly DW
PY  - 2026
DA  - 2026/11/05
JO  - Medical Devices: Evidence and Research
UR  - https://www.dovepress.com/navigating-porous-threaded-implants-across-the-si-joint-is-associated--peer-reviewed-fulltext-article-MDER
AB  - Sharad Rajpal,1 Arjun Joshi,2 Daniel Cher,3 David W Polly41Neurosurgery, AdventHealth, Louisville, CO, USA; 2Product Marketing, SI-BONE, Inc., San Jose, CA, USA; 3Regulatory Affairs, SI-BONE, Inc., San Jose, CA, USA; 4Department of Orthopedics, University of Minnesota, Minneapolis, MN, USACorrespondence: Daniel Cher, Regulatory Affairs, SI-BONE, Inc., 88. W. Plumeria Drive, San Jose, CA, 95134, USA, Email [email protected]: To determine whether use of intraoperative navigation is associated with a reduced rate of acute symptomatic implant malposition during iliosacral implant placement in sacroiliac (SI) joint fusion and sacral fracture fixation.Methods: Retrospective analysis of post-market databases regarding device use and reported device-related complaints from a single device manufacturer between March 2021 and August 2026 were combined, including procedure type, procedure date and use of navigation systems. Analysis focused on lateral and posterolateral (PL) transiliac placement of a porous threaded implant (PTI, iFuse TORQ) during SI joint fusion and sacral fracture fixation procedures performed in the USA. All acute symptomatic implant malpositions reported as product complaints were identified and linked to index surgeries through manual identification. The proportion of navigated and non-navigated cases that resulted in symptomatic implant malposition was compared using Firth’s penalized logistic regression test.Results: 25,096 procedures using 68,352 PTI were identified. Navigation was used in 15.6% (n=3,919) of cases. Implant malposition causing acute symptoms occurred in 63 cases (overall rate 0.25%). Of these, 2 occurred in navigated cases (rate, 0.05%) and 61 occurred in non-navigated cases (rate, 0.29%, odds ratio 0.22, 95% CI 0.046– 0.639, p=0.0014).Conclusion: Navigation was associated with a markedly lower rate of acute symptomatic implant malposition during lateral or PL transiliac placement of a PTI.Plain Language Summary: Sacroiliac joint fusion is a widely accepted and performed procedures. Implant placement can be guided fluoroscopically or by navigation systems. Navigation systems are generally thought to allow more accurate implant placement.A manufacturer reviewed reported instances of acute symptomatic implant malposition in > 25,000 cases of SI joint fusion or pelvic fracture fixation surgeries using a porous threaded implant (iFuse TORQ, SI-BONE, Inc). Implant malposition occurred in 61 cases (rate of 0.29%) guided fluoroscopically and 2 cases (rate of 0.05%) guided with navigation systems (odds ratio 0.220, p=0.0014). The large rate difference is unlikely to be due to underreporting. These findings support the use of navigation during pelvic surgery to reduce symptomatic implant malposition.Keywords: porous threaded implants, sacroiliac joint arthrodesis, navigation, stereotactic surgery, implant malposition
SN  - 1179-1470
ER  -