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

NCT05367505 | Recruiting DMC

• 1 other identifier: TIKTIS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pelvic Fracture; Insufficiency Fractures; Mobility Limitation

Keywords

Fracture Fixation; Fragility Fractures; Pelvis; Surgical Procedures; Minimal Invasive

Outcome Measures

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 8 days (discharge) after surgery

Secondary Outcomes (30)

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

  Time six weeks after surgery

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

  Time three months after surgery

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

  Time six months after surgery

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

  Time 12 months after surgery

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

  Time 8 days (discharge) after surgery

Study Arms (1)

iFuse-3D

EXPERIMENTAL

Titanium fusion implant in combination with trans-iliac screws

Device: iFuse-3D implant

Interventions

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.

iFuse-3D

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• SI-BONE, Inc.: collaborator
• Johannes Gutenberg University Mainz: collaborator

Study Sites (3)

Diakonie Krankenhaus

Bad Kreuznach, 55543, Germany

RECRUITING

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, 55131, Germany

RECRUITING

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

RECRUITING

Related Publications (12)

• 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.

  PMID: 24762143 BACKGROUND

• 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.

  PMID: 29684740 BACKGROUND

• 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.

  PMID: 26319676 BACKGROUND

• 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.

  PMID: 24419459 BACKGROUND

• 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.

  PMID: 26418971 BACKGROUND

• 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.

  PMID: 27448040 BACKGROUND

• 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.

  PMID: 28359073 BACKGROUND

• 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.

  PMID: 27077891 BACKGROUND

• 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.

  PMID: 21513936 BACKGROUND

• 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.

  PMID: 28272751 BACKGROUND

• 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.

  PMID: 34844577 BACKGROUND

• 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.

  PMID: 23178479 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Fractures, Stress; Mobility Limitation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erol Gercek, Prof.

  University Medical Center of the Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Graf

CONTACT

+49 202 896; katharina.graf@uni-wh.de

René Geißen, Dr.

CONTACT

+49 202 896; rene.geissen@uni-wh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 10, 2022
• Study Start: January 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

DE (3)