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

Overview
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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.

Programme: ZKS-UWH

SEEK ID: https://ldh.zks-uwh.imise.uni-leipzig.de/projects/3

Public web page: Not specified

NFDI4Health PALs: Katharina Graf, Rebekka van Zyl

Project start date: 9th Jan 2023

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-30008

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Language of the title/name : English

Acronym(s) of the Project

Acronym : TIKTIS
Language of the acronym : German

Description(s) of the Project

Description : 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.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Fracture Fixation

Keyword(*) : Fragility Fractures

Keyword(*) : Pelvis

Keyword(*) : Surgical Procedures

Keyword(*) : Minimal Invasive

Language(s) of the project : German

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Witten/Herdecke University
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : zks@uni-wh.de
Phone number : +49 202 896-5613
Organisation(s) associated with the contributor
Name(*) : Centre for Clinical Trials Witten/Herdecke University
Address : Alfred-Herrhausen-Str. 50, 58448 Witten
Web page : Not specified
Digital identifier(s)
Identifier(*) : 00yq55g44
Scheme(*) : ROR

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Erol
Family name(s)(*) : Gercek
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : erol.gercek@unimedizin-mainz.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : University Medical Center of the Johannes Gutenberg University Mainz
Address : Langenbeckstraße 1, 55131 Mainz
Web page : Not specified
Digital identifier(s)
Identifier(*) : https://ror.org/00q1fsf04
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT05367505

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Single group
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Insufficiency Fractures of the Pelvis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : S32.89
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the musculoskeletal system and connective tissue (XIII)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (II): Recruitment and data collection ongoing
Participants enrolled by invitation? : Yes
Start date : 9 January 2023
End date : Not specified
Mono- or multicentric? : Monocentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 60
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
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
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Mainz, Bad Kreuznach, Wuppertal, München
Interventions of the Project
Name of the intervention(*) : Titanium fusion implant in combination with trans-iliac screws
Type of the intervention : Device (including sham)
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : Time 8 days (discharge) after surgery
Name of the outcome measure(*) : Proportion of patients who achieve pre-fracture mobility within six weeks
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Time six weeks after surgery
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : No
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Other
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not applicable (for single-arm trials)
Off-label use of a drug product : Not specified

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

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