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Active, not recruitingNCT05367505TIKTISUpdated Jun 23, 2026

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

An interventional study of iFuse-3D implant in Pelvic Fracture, Insufficiency Fractures and Mobility Limitation, sponsored by University of Witten/Herdecke. Active, not recruiting at 3 sites in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by University of Witten/Herdecke · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pelvic Fracture
  • Insufficiency Fractures
  • Mobility Limitation

Keywords

  • Fracture Fixation
  • Fragility Fractures
  • Pelvis
  • Surgical Procedures
  • Minimal Invasive
03

In context

Hip Fractures

842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.

This study's enrollment of 50 is below the median of 86 across 533 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

University of Witten/Herdecke is the lead sponsor of 40 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. , severe heart failure, Parkinson's disease, 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    iFuse-3D

    Titanium fusion implant in combination with trans-iliac screws

    Device: iFuse-3D implant

Interventions

  • DeviceiFuse-3D implant

    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.

06

What researchers measure

Primary outcomes

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time 8 days (discharge) after surgery

Secondary outcomes

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time six weeks after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time three months after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time six months after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time 12 months after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time 8 days (discharge) after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time six weeks after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time three months after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time six months after surgery

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

    The proportion is shown with frequencies and corresponding percentages.

    Time frame: Time 12 months after surgery

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

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

    Time frame: Time six weeks after surgery

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

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

    Time frame: Time three months after surgery

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

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

    Time frame: Time six months after surgery

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

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

    Time frame: Time 12 months after surgery

  14. Timed up and go test after six weeks.

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

    Time frame: Time six weeks after surgery

  15. Timed up and go test after three months.

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

    Time frame: Time three months after surgery

  16. Timed up and go test after six months.

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

    Time frame: Time six months after surgery

  17. Timed up and go test after 12 months.

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

    Time frame: Time 12 months after surgery

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

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

    Time frame: Time six weeks after surgery

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

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

    Time frame: Time three months after surgery

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

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

    Time frame: Time six months after surgery

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

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

    Time frame: Time 12 months after surgery

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

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

    Time frame: Time six weeks after surgery

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

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

    Time frame: Time three months after surgery

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

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

    Time frame: Time six months after surgery

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

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

    Time frame: Time 12 months after surgery

  26. Proportion of screws or iFuse fractures.

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

    Time frame: Time within 12 months

  27. Proportion of screw sintering.

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

    Time frame: Time within 12 months

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

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

    Time frame: Time within 12 months

  29. Proportion of radiological signs of loosening.

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

    Time frame: Time within 12 months

  30. Proportion of infections.

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

    Time frame: Time within 12 months

07

Study locations

3 sites
08

References and documents

Publications

  • Sullivan MP, Baldwin KD, Donegan DJ, Mehta S, Ahn J. Geriatric fractures about the hip: divergent patterns in the proximal femur, acetabulum, and pelvis. Orthopedics. 2014 Mar;37(3):151-7. doi: 10.3928/01477447-20140225-50. PubMed 24762143 ↗
  • Kannus P, Niemi S, Parkkari J, Sievanen H. Continuously declining incidence of hip fracture in Finland: Analysis of nationwide database in 1970-2016. Arch Gerontol Geriatr. 2018 Jul-Aug;77:64-67. doi: 10.1016/j.archger.2018.04.008. Epub 2018 Apr 17. PubMed 29684740 ↗
  • Kannus P, Parkkari J, Niemi S, Sievanen H. Low-Trauma Pelvic Fractures in Elderly Finns in 1970-2013. Calcif Tissue Int. 2015 Dec;97(6):577-80. doi: 10.1007/s00223-015-0056-8. Epub 2015 Aug 29. PubMed 26319676 ↗
  • Nanninga GL, de Leur K, Panneman MJ, van der Elst M, Hartholt KA. Increasing rates of pelvic fractures among older adults: The Netherlands, 1986-2011. Age Ageing. 2014 Sep;43(5):648-53. doi: 10.1093/ageing/aft212. Epub 2014 Jan 12. PubMed 24419459 ↗
  • Andrich S, Haastert B, Neuhaus E, Neidert K, Arend W, Ohmann C, Grebe J, Vogt A, Jungbluth P, Rosler G, Windolf J, Icks A. Epidemiology of Pelvic Fractures in Germany: Considerably High Incidence Rates among Older People. PLoS One. 2015 Sep 29;10(9):e0139078. doi: 10.1371/journal.pone.0139078. eCollection 2015. PubMed 26418971 ↗
  • Maier GS, Kolbow K, Lazovic D, Horas K, Roth KE, Seeger JB, Maus U. Risk factors for pelvic insufficiency fractures and outcome after conservative therapy. Arch Gerontol Geriatr. 2016 Nov-Dec;67:80-5. doi: 10.1016/j.archger.2016.06.020. Epub 2016 Jul 15. PubMed 27448040 ↗
  • Rommens PM, Wagner D, Hofmann A. Fragility Fractures of the Pelvis. JBJS Rev. 2017 Mar 21;5(3):e3. doi: 10.2106/JBJS.RVW.16.00057. No abstract available. PubMed 28359073 ↗
  • Breuil V, Roux CH, Carle GF. Pelvic fractures: epidemiology, consequences, and medical management. Curr Opin Rheumatol. 2016 Jul;28(4):442-7. doi: 10.1097/BOR.0000000000000293. PubMed 27077891 ↗
  • Pohlemann T, Stengel D, Tosounidis G, Reilmann H, Stuby F, Stockle U, Seekamp A, Schmal H, Thannheimer A, Holmenschlager F, Gansslen A, Rommens PM, Fuchs T, Baumgartel F, Marintschev I, Krischak G, Wunder S, Tscherne H, Culemann U. Survival trends and predictors of mortality in severe pelvic trauma: estimates from the German Pelvic Trauma Registry Initiative. Injury. 2011 Oct;42(10):997-1002. doi: 10.1016/j.injury.2011.03.053. Epub 2011 Apr 22. PubMed 21513936 ↗
  • Andrich S, Haastert B, Neuhaus E, Neidert K, Arend W, Ohmann C, Grebe J, Vogt A, Jungbluth P, Thelen S, Windolf J, Icks A. Excess Mortality After Pelvic Fractures Among Older People. J Bone Miner Res. 2017 Sep;32(9):1789-1801. doi: 10.1002/jbmr.3116. Epub 2017 May 8. PubMed 28272751 ↗
  • Ullrich BW, Schnake KJ, Spiegl UJA, Schenk P, Mendel T, Behr L, Bula P, Flucht LB, Franck A, Gercek E, Gruninger S, Hartung P, Jacobs C, Katscher S, Klauke F, Liepold K, Muller CW, Muller M, Osterhoff G, Partenheimer A, Piltz S, Riehle M, Sauer D, Scheyerer MJ, Schleicher P, Schmeiser G, Schmidt R, Scholz M, Siekmann H, Sprengel K, Stoevesandt D, Verheyden A, Zimmermann V; Spine Section of the German Society for Orthopaedics and Trauma. OF-Pelvis classification of osteoporotic sacral and pelvic ring fractures. BMC Musculoskelet Disord. 2021 Nov 29;22(1):992. doi: 10.1186/s12891-021-04882-6. PubMed 34844577 ↗
  • Hammer N, Lingslebe U, Aust G, Milani TL, Hadrich C, Steinke H. Ultimate stress and age-dependent deformation characteristics of the iliotibial tract. J Mech Behav Biomed Mater. 2012 Dec;16:81-6. doi: 10.1016/j.jmbbm.2012.04.025. Epub 2012 Oct 30. PubMed 23178479 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05367505
Lead sponsor
University of Witten/Herdecke
Collaborators
SI-BONE, Inc., Johannes Gutenberg University Mainz
Responsible party
Sponsor
First posted
May 10, 2022
Start date
Jan 9, 2023
Primary completion
Jun 7, 2027 (estimated)
Completion
Feb 7, 2028 (estimated)
Last update
Jun 23, 2026

Study contacts

Erol Gercek, Prof.
principal investigator · University Medical Center of the Johannes Gutenberg University Mainz

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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