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NCT Number: NCT05367505

Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps.

The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients.

The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.

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Key information

Conditions

Pelvic Fracture Femoral Fractures Fractures, Bone Fractures, Stress Hip Fractures Hip Injuries Insufficiency Fractures Leg Injuries Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonie Krankenhaus, Bad Kreuznach, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Legal capacity, capacity to inform
  • Presence of a written declaration of consent by the patient
  • Age: ≥ 60 years
  • Acute or subacute (less than 2 months) posterior pelvic girdle pain associated with low energy trauma or occurring spontaneously
  • Diagnosis confirmed by CT and/or MRI
  • The fracture corresponds to types OF3 and OF4 of the OF Pelvis classification.
  • Prior to the fracture, there was free, non-wheelchair mobility (Functional Mobility Score of 2 or higher)

Exclusion criteria

  • Diagnosed uncontrolled psychiatric illness (e.g. dementia, schizophrenia, major depression, personality disorder) that could affect study participation or reporting of findings
  • History of pelvic fracture within one year with evidence of failure of fracture to heal or internal fixation of the pelvic ring of any type
  • Patients unable to ambulate before the fracture
  • Patient has had lumbar instrumentation of more than two vertebrae and/or instrumentation of S1 in the past
  • Additional fractures that limit mobility
  • OF-P associated with benign or malignant tumours of the pelvis
  • Abnormal neurological condition that could affect study participation
  • An unusual clinical condition associated with a high risk of not being able to follow up (e.g. COPD, severe heart failure, Parkinson's disease, autoimmune diseases)
  • Any pelvic condition or anatomical feature that makes surgery impracticable
  • Known allergy to titanium or titanium alloys
  • Known opioid abuse for chronic pain syndromes
  • Participation in other interventional trials
  • Lack of surgical capability
  • Persons in a dependent/employee relationship with the sponsor or investigator
  • Placement in an institution due to court or administrative order.

Treatment and study plan

iFuse-3D implant

Device

The iFuse Implant System consists of cannulated triangular titanium implants (Ti 6AI4V ELI, ASTM F136) with a porous coating of commercially pure titanium plasma spray (C.P. Ti, ASTM F1580) and a setting instrument. The coating and special shape of the implants prevent rotation or displacement of the sacroiliac (SI) joint. The placement instrument uses guide pins to achieve precise placement.

Primary outcomes

  1. Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge

    Time frame: Time 8 days (discharge) after surgery

    The proportion is shown with frequencies and corresponding percentages.

Secondary outcomes

  1. Proportion of patients who achieve pre-fracture mobility within six weeks.

    Time frame: Time six weeks after surgery

    The proportion is shown with frequencies and corresponding percentages.

  2. Proportion of patients who achieve pre-fracture mobility at three months.

    Time frame: Time three months after surgery

    The proportion is shown with frequencies and corresponding percentages.

  3. Proportion of patients who achieve pre-fracture mobility at six months.

    Time frame: Time six months after surgery

    The proportion is shown with frequencies and corresponding percentages.

  4. Proportion of patients who achieve pre-fracture mobility at 12 months.

    Time frame: Time 12 months after surgery

    The proportion is shown with frequencies and corresponding percentages.

  5. Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge.

    Time frame: Time 8 days (discharge) after surgery

    The proportion is shown with frequencies and corresponding percentages.

  6. Proportion of patients who achieved an FMS ≥ 2 within six weeks.

    Time frame: Time six weeks after surgery

    The proportion is shown with frequencies and corresponding percentages.

  7. Proportion of patients who achieved an FMS ≥ 2 at three months.

    Time frame: Time three months after surgery

    The proportion is shown with frequencies and corresponding percentages.

  8. Proportion of patients who achieved an FMS ≥ 2 at six months.

    Time frame: Time six months after surgery

    The proportion is shown with frequencies and corresponding percentages.

  9. Proportion of patients who achieved an FMS ≥ 2 at 12 months.

    Time frame: Time 12 months after surgery

    The proportion is shown with frequencies and corresponding percentages.

  10. Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) within six weeks.

    Time frame: Time six weeks after surgery

    Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.

  11. Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at three months.

    Time frame: Time three months after surgery

    Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.

  12. Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at six months.

    Time frame: Time six months after surgery

    Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.

  13. Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at 12 months.

    Time frame: Time 12 months after surgery

    Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.

  14. Timed up and go test after six weeks.

    Time frame: Time six weeks after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  15. Timed up and go test after three months.

    Time frame: Time three months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  16. Timed up and go test after six months.

    Time frame: Time six months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  17. Timed up and go test after 12 months.

    Time frame: Time 12 months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  18. Opioid consumption and osteoporosis medication in the last six weeks.

    Time frame: Time six weeks after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  19. Opioid consumption and osteoporosis medication in the last three months.

    Time frame: Time three months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  20. Opioid consumption and osteoporosis medication in the last six months.

    Time frame: Time six months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  21. Opioid consumption and osteoporosis medication in the last 12 months.

    Time frame: Time 12 months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  22. Change in quality of life measured by the EuroQol-5D-3L after six weeks.

    Time frame: Time six weeks after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  23. Change in quality of life measured by the EuroQol-5D-3L after three months.

    Time frame: Time three months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  24. Change in quality of life measured by the EuroQol-5D-3L after six months.

    Time frame: Time six months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  25. Change in quality of life measured by the EuroQol-5D-3L after 12 months.

    Time frame: Time 12 months after surgery

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.

  26. Proportion of screws or iFuse fractures.

    Time frame: Time within 12 months

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.

  27. Proportion of screw sintering.

    Time frame: Time within 12 months

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.

  28. Proportion of sintering/migration of the iFuse implant.

    Time frame: Time within 12 months

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.

  29. Proportion of radiological signs of loosening.

    Time frame: Time within 12 months

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.

  30. Proportion of infections.

    Time frame: Time within 12 months

    Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Collaborators

  • Johannes Gutenberg University Mainz
  • SI-BONE, Inc.

Registry information

Official study title

Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

Acronym: TIKTIS

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 10, 2022
Registry last updated
Jun 23, 2026

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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