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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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
Are there results?: Not yet: the study is under way

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

Show all 15Show fewer

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

Other trials in Germany

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

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.

Conditions: Pelvic Fracture, Insufficiency Fractures, Mobility Limitation
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 groups in NCT05367505
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.

9 Jan 20237 Feb 2028

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)

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 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
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Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
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All Pelvic Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
ClinicalTrials.gov ID: NCT05367505
Acronym / sponsor ID: TIKTIS / TIKTIS
Conditions: Pelvic Fracture, Insufficiency Fractures, Mobility Limitation
Keywords: Fracture Fixation, Fragility Fractures, Pelvis, Surgical Procedures, Minimal Invasive
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 50 participants (actual)
Lead sponsor: University of Witten/HerdeckeUniversity, hospital or other
Collaborators: SI-BONE, Inc., Johannes Gutenberg University Mainz
Study start: 9 Jan 2023 (actual)
Primary completion: 7 Jun 2027 (estimated)
Study completion: 7 Feb 2028 (estimated)
First posted: 10 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
iFuse-3D	Experimental	Device: iFuse-3D implantTitanium fusion implant in combination with trans-iliac screws

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iFuse-3D implantThe 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.	Device	iFuse-3D

Primary outcome

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.

30 secondary outcomes

Proportion of patients who achieve pre-fracture mobility within six weeks.
Time frame: Time six weeks after surgery
Proportion of patients who achieve pre-fracture mobility at three months.
Time frame: Time three months after surgery
Proportion of patients who achieve pre-fracture mobility at six months.
Time frame: Time six months after surgery
Proportion of patients who achieve pre-fracture mobility at 12 months.
Time frame: Time 12 months after surgery
Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge.
Time frame: Time 8 days (discharge) after surgery
Proportion of patients who achieved an FMS ≥ 2 within six weeks.
Time frame: Time six weeks after surgery
Proportion of patients who achieved an FMS ≥ 2 at three months.
Time frame: Time three months after surgery
Proportion of patients who achieved an FMS ≥ 2 at six months.
Time frame: Time six months after surgery
Proportion of patients who achieved an FMS ≥ 2 at 12 months.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Time 12 months after surgery
Timed up and go test after six weeks.
Time frame: Time six weeks after surgery
Timed up and go test after three months.
Time frame: Time three months after surgery
Timed up and go test after six months.
Time frame: Time six months after surgery
Timed up and go test after 12 months.
Time frame: Time 12 months after surgery
Opioid consumption and osteoporosis medication in the last six weeks.
Time frame: Time six weeks after surgery
Opioid consumption and osteoporosis medication in the last three months.
Time frame: Time three months after surgery
Opioid consumption and osteoporosis medication in the last six months.
Time frame: Time six months after surgery
Opioid consumption and osteoporosis medication in the last 12 months.
Time frame: Time 12 months after surgery
Change in quality of life measured by the EuroQol-5D-3L after six weeks.
Time frame: Time six weeks after surgery
Change in quality of life measured by the EuroQol-5D-3L after three months.
Time frame: Time three months after surgery
Change in quality of life measured by the EuroQol-5D-3L after six months.
Time frame: Time six months after surgery
Change in quality of life measured by the EuroQol-5D-3L after 12 months.
Time frame: Time 12 months after surgery
Proportion of screws or iFuse fractures.
Time frame: Time within 12 months
Proportion of screw sintering.
Time frame: Time within 12 months
Proportion of sintering/migration of the iFuse implant.
Time frame: Time within 12 months
Proportion of radiological signs of loosening.
Time frame: Time within 12 months
Proportion of infections.
Time frame: Time within 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Background: PubMed 24762143Sullivan 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.
Background: PubMed 29684740Kannus 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.
Background: PubMed 26319676Kannus 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.
Background: PubMed 24419459Nanninga 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.
Background: PubMed 26418971Andrich 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.
Background: PubMed 27448040Maier 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.
Background: PubMed 28359073Rommens 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.
Background: PubMed 27077891Breuil 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.
Background: PubMed 21513936Pohlemann 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.
Background: PubMed 28272751Andrich 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.
Background: PubMed 34844577Ullrich 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.
Background: PubMed 23178479Hammer 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.

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Hip Fracture Surgeries, High Risk Population of Hip Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erol Gercek, Prof. principal investigator

University Medical Center of the Johannes Gutenberg University Mainz

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367505, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.