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NCT Number: NCT02270203

LOIS: Long-Term Follow-Up in INSITE/SIFI

The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).

Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:

* SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and * INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement

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Key information

Conditions

Degenerative Sacroilitis Sacroiliac Joint Disruption

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.
  • Patient has signed study-specific LOIS informed consent form.
  • Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.

Exclusion criteria

  • Treated with iFuse as a "crossover" in INSITE.
  • Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
  • Patient is a prisoner or a ward of the state.
  • Known or suspected active drug or alcohol abuse.
  • Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
  • Unwilling to perform the long-term follow up requirements of this study.
  • Patient has any condition that could substantially prevent long-term follow-up.
  • Unwilling to return to site at pre-specified study visits.

Treatment and study plan

Pelvic CT at 5 years post-op

Radiation

Pelvic CT at 5 years post-op

Primary outcomes

  1. Subject Success

    Time frame: 3 years on LOIS (5 years post-op)

    Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,& Absence of surgical re-intervention on the target SI joint(s).

  2. Radiographic (CT) apposition of bone to sacral and iliac sides of implant

    Time frame: 3 years on LOIS (5 years post-op)

    Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.

Secondary outcomes

  1. VAS (Visual Analog Scale)

    Time frame: 3 years on LOIS (5 years post-op)

    Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.

  2. Oswestry Disability Index (ODI) Questionnaire

    Time frame: 3 years on LOIS (5 years post-op)

    Improvement in Oswestry Disability Index (ODI) at follow-up visits.

  3. Improvement in quality of life (QOL)

    Time frame: 3 years on LOIS (5 years post-op)

    Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.

  4. non-working subjects returning to work

    Time frame: 3 years on LOIS (5 years post-op)

    Proportion of non-working subjects who return to work

  5. CT scans showing bridging bone

    Time frame: 3 years on LOIS (5 years post-op)

    Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively

  6. SAE (Serious Adverse Events) occurrence rate

    Time frame: 3 years on LOIS

    Occurrence rate of serious adverse events.

Sponsors and collaborators

Lead sponsor

SI-BONE, Inc.

Industry

Registry information

Acronym: LOIS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2014
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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