Pelvic FractureTIKTISNCT05367505
Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
A study testing iFuse-3D implant in people with Pelvic Fracture and Insufficiency Fractures, run by University of Witten/Herdecke at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pelvic Fracture, Insufficiency Fractures, Mobility Limitation
- What is being tested?
- iFuse-3D implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesGermany
- Study dates
- 9 Jan 2023to 7 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Diakonie Krankenhaus
Bad Kreuznach, 55543
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, 55131
Helios Universitätsklinikum Wuppertal
Wuppertal, 42283
About this study
Official title: Prospective Pilot Study With a 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.
- Being tested
- iFuse-3D implant
- Keywords
- Fracture Fixation, Fragility Fractures, Pelvis, Surgical Procedures, Minimal Invasive
- Medical subject headings
- Hip Fractures, Fractures, Stress, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuse-3D implantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| iFuse-3D | Experimental | Titanium fusion implant in combination with trans-iliac screws Receives: Device: iFuse-3D implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time 8 days (discharge) after surgery
Secondary outcomes (30)
Proportion of patients who achieve pre-fracture mobility within six weeks.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time six weeks after surgery
Proportion of patients who achieve pre-fracture mobility at three months.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time three months after surgery
Proportion of patients who achieve pre-fracture mobility at six months.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time six months after surgery
Proportion of patients who achieve pre-fracture mobility at 12 months.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time 12 months after surgery
Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time 8 days (discharge) after surgery
Proportion of patients who achieved an FMS ≥ 2 within six weeks.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time six weeks after surgery
Proportion of patients who achieved an FMS ≥ 2 at three months.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time three months after surgery
Proportion of patients who achieved an FMS ≥ 2 at six months.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time six months after surgery
Proportion of patients who achieved an FMS ≥ 2 at 12 months.
The proportion is shown with frequencies and corresponding percentages.
Measured: Time 12 months after surgery
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.
Measured: Time six weeks after surgery
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.
Measured: Time three months after surgery
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.
Measured: Time six months after surgery
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.
Measured: Time 12 months after surgery
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.
Measured: Time six weeks after surgery
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.
Measured: Time three months after surgery
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.
Measured: Time six months after surgery
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.
Measured: Time 12 months after surgery
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.
Measured: Time six weeks after surgery
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.
Measured: Time three months after surgery
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.
Measured: Time six months after surgery
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.
Measured: Time 12 months after surgery
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.
Measured: Time six weeks after surgery
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.
Measured: Time three months after surgery
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.
Measured: Time six months after surgery
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.
Measured: Time 12 months after surgery
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.
Measured: Time within 12 months
Proportion of screw sintering.
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
Measured: Time within 12 months
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.
Measured: Time within 12 months
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.
Measured: Time within 12 months
Proportion of infections.
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
Measured: Time within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start9 Jan 2023
- Primary completion7 Jun 2027 (estimated)
- Study completion7 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- SI-BONE, Inc., Johannes Gutenberg University Mainz
- Responsible party
- Sponsor
- Investigators
- Erol Gercek, Prof., Principal investigator, University Medical Center of the Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367505
- Sponsor's protocol ID
- TIKTIS
- Acronym
- TIKTIS
- Status last verified
- Jun 2026
- First submitted
- 4 May 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 24762143Kannus 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 29684740Kannus 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 26319676Nanninga 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 24419459Andrich 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 26418971Maier 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 27448040Rommens 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 28359073Breuil 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 27077891Pohlemann 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 21513936Andrich 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 28272751Ullrich 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 34844577Hammer 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