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

Primary Purpose

Pelvic Fracture, Insufficiency Fractures, Mobility Limitation

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
iFuse-3D implant
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Fracture focused on measuring Fracture Fixation, Fragility Fractures, Pelvis, Surgical Procedures, Minimal Invasive

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Diakonie KrankenhausRecruiting
  • University Medical Center of the Johannes Gutenberg University Mainz
  • Helios Universitätsklinikum WuppertalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iFuse-3D

Arm Description

Titanium fusion implant in combination with trans-iliac screws

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients who achieve pre-fracture mobility within six weeks.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieve pre-fracture mobility at three months.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieve pre-fracture mobility at six months.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieve pre-fracture mobility at 12 months.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieved an FMS ≥ 2 within six weeks.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieved an FMS ≥ 2 at three months.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieved an FMS ≥ 2 at six months.
The proportion is shown with frequencies and corresponding percentages.
Proportion of patients who achieved an FMS ≥ 2 at 12 months.
The proportion is shown with frequencies and corresponding percentages.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Proportion of screw sintering.
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
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.
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.
Proportion of infections.
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.

Full Information

First Posted
May 4, 2022
Last Updated
April 3, 2023
Sponsor
University of Witten/Herdecke
Collaborators
SI-BONE, Inc., Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT05367505
Brief Title
Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Acronym
TIKTIS
Official Title
Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Witten/Herdecke
Collaborators
SI-BONE, Inc., Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Fracture, Insufficiency Fractures, Mobility Limitation
Keywords
Fracture Fixation, Fragility Fractures, Pelvis, Surgical Procedures, Minimal Invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iFuse-3D
Arm Type
Experimental
Arm Description
Titanium fusion implant in combination with trans-iliac screws
Intervention Type
Device
Intervention Name(s)
iFuse-3D implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time 8 days (discharge) after surgery
Secondary Outcome Measure Information:
Title
Proportion of patients who achieve pre-fracture mobility within six weeks.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time six weeks after surgery
Title
Proportion of patients who achieve pre-fracture mobility at three months.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time three months after surgery
Title
Proportion of patients who achieve pre-fracture mobility at six months.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time six months after surgery
Title
Proportion of patients who achieve pre-fracture mobility at 12 months.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time 12 months after surgery
Title
Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time 8 days (discharge) after surgery
Title
Proportion of patients who achieved an FMS ≥ 2 within six weeks.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time six weeks after surgery
Title
Proportion of patients who achieved an FMS ≥ 2 at three months.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time three months after surgery
Title
Proportion of patients who achieved an FMS ≥ 2 at six months.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time six months after surgery
Title
Proportion of patients who achieved an FMS ≥ 2 at 12 months.
Description
The proportion is shown with frequencies and corresponding percentages.
Time Frame
Time 12 months after surgery
Title
Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) within six weeks.
Description
Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six weeks after surgery
Title
Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at three months.
Description
Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time three months after surgery
Title
Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at six months.
Description
Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six months after surgery
Title
Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at 12 months.
Description
Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time 12 months after surgery
Title
Timed up and go test after six weeks.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six weeks after surgery
Title
Timed up and go test after three months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time three months after surgery
Title
Timed up and go test after six months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six months after surgery
Title
Timed up and go test after 12 months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time 12 months after surgery
Title
Opioid consumption and osteoporosis medication in the last six weeks.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six weeks after surgery
Title
Opioid consumption and osteoporosis medication in the last three months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time three months after surgery
Title
Opioid consumption and osteoporosis medication in the last six months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six months after surgery
Title
Opioid consumption and osteoporosis medication in the last 12 months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time 12 months after surgery
Title
Change in quality of life measured by the EuroQol-5D-3L after six weeks.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six weeks after surgery
Title
Change in quality of life measured by the EuroQol-5D-3L after three months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time three months after surgery
Title
Change in quality of life measured by the EuroQol-5D-3L after six months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time six months after surgery
Title
Change in quality of life measured by the EuroQol-5D-3L after 12 months.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied.
Time Frame
Time 12 months after surgery
Title
Proportion of screws or iFuse fractures.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
Time Frame
Time within 12 months
Title
Proportion of screw sintering.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
Time Frame
Time within 12 months
Title
Proportion of sintering/migration of the iFuse implant.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
Time Frame
Time within 12 months
Title
Proportion of radiological signs of loosening.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
Time Frame
Time within 12 months
Title
Proportion of infections.
Description
Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied.
Time Frame
Time within 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Graf
Phone
+49 202 896
Ext
5614
Email
katharina.graf@uni-wh.de
First Name & Middle Initial & Last Name or Official Title & Degree
René Geißen, Dr.
Phone
+49 202 896
Ext
5613
Email
rene.geissen@uni-wh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erol Gercek, Prof.
Organizational Affiliation
University Medical Center of the Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonie Krankenhaus
City
Bad Kreuznach
ZIP/Postal Code
55543
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Hartmann, Prof. Dr.
Email
hartmafr@kreuznacherdiakonie.de
Facility Name
University Medical Center of the Johannes Gutenberg University Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erol Gercek, Prof.
Email
erol.gercek@unimedizin-mainz.de
Facility Name
Helios Universitätsklinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koroush Kabir, Dr.
Phone
+49 202 896-3301
Email
koroush.kabir@helios-gesundheit.de
First Name & Middle Initial & Last Name & Degree
Koroush Kabir, Dr.

12. IPD Sharing Statement

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

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