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

Mobility Limitation Clinical Trial

— TIKTIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05367505
• Other study ID #: TIKTIS
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: University of Witten/Herdecke
• Contact: Katharina Graf
• Phone: +49 202 896
• Email: katharina.graf[@]uni-wh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Hip Fractures
• Insufficiency Fractures
• Mobility Limitation
• Pelvic Fracture

Intervention

Device:
• iFuse-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.

Locations

Country	Name	City	State
Germany	Diakonie Krankenhaus	Bad Kreuznach
Germany	University Medical Center of the Johannes Gutenberg University Mainz	Mainz
Germany	Helios Universitätsklinikum Wuppertal	Wuppertal

Sponsors (3)

Lead Sponsor	Collaborator
University of Witten/Herdecke	Johannes Gutenberg University Mainz, SI-BONE, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients who achieve pre-fracture mobility within six weeks.	The proportion is shown with frequencies and corresponding percentages.	Time six weeks after surgery
Secondary	Proportion of patients who achieve pre-fracture mobility at three months.	The proportion is shown with frequencies and corresponding percentages.	Time three months after surgery
Secondary	Proportion of patients who achieve pre-fracture mobility at six months.	The proportion is shown with frequencies and corresponding percentages.	Time six months after surgery
Secondary	Proportion of patients who achieve pre-fracture mobility at 12 months.	The proportion is shown with frequencies and corresponding percentages.	Time 12 months after surgery
Secondary	Proportion of patients who achieved an FMS = 2 (= walking with assistive devices) at discharge.	The proportion is shown with frequencies and corresponding percentages.	Time 8 days (discharge) after surgery
Secondary	Proportion of patients who achieved an FMS = 2 within six weeks.	The proportion is shown with frequencies and corresponding percentages.	Time six weeks after surgery
Secondary	Proportion of patients who achieved an FMS = 2 at three months.	The proportion is shown with frequencies and corresponding percentages.	Time three months after surgery
Secondary	Proportion of patients who achieved an FMS = 2 at six months.	The proportion is shown with frequencies and corresponding percentages.	Time six months after surgery
Secondary	Proportion of patients who achieved an FMS = 2 at 12 months.	The proportion is shown with frequencies and corresponding percentages.	Time 12 months after surgery
Secondary	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 six weeks after surgery
Secondary	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 three months after surgery
Secondary	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 six months after surgery
Secondary	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 12 months after surgery
Secondary	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 six weeks after surgery
Secondary	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 three months after surgery
Secondary	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 six months after surgery
Secondary	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 12 months after surgery
Secondary	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 six weeks after surgery
Secondary	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 three months after surgery
Secondary	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 six months after surgery
Secondary	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 12 months after surgery
Secondary	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 six weeks after surgery
Secondary	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 three months after surgery
Secondary	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 six months after surgery
Secondary	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 12 months after surgery
Secondary	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 within 12 months
Secondary	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 within 12 months
Secondary	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 within 12 months
Secondary	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 within 12 months
Secondary	Proportion of infections.	Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.	Time within 12 months