Assessing Cement-bone Incorporation and Adjacent Segment... | NCT03369288

Studies
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up

NCT03369288

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Oct 30, 2018Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Vertebral Fracture
Cement Augmentation

Interventions

PET MRI

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2017Actual

Primary Completion Date

Jun 28, 2019Estimated

Completion Date

Nov 28, 2019Estimated

First Submitted Date

Dec 5, 2017

First Submission Date that Met QC Criteria

Dec 5, 2017

First Posted Date

Dec 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2018

Last Update Posted Date

Oct 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
PET MRI	Diagnostic Test	18F-fluoride PET-MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tracer Uptake	Perifokal tracer uptake at the cement-bone border	at least 3 years after kyphoplasty

Secondary Outcomes

Measure	Description	Time Frame
Intravertebral Discs	Tracer uptake within the intravertebral disc and morphological changes	at least 3 years after kyphoplasty

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Men and women aged 18 to 70 years
Minimum 3-year follow-up
Single-level vertebral kyphoplasty
Index surgery at UniversitätsSpital Zürich
MRI-scan during initial treatment
Informed consent provided

Exclusion criteria

Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
Intraoperative intradiscal cement leakage
Previous history of spinal surgery except on the cervical spine
Metastatic disease with skeletal involvement
Known chronic diseases of the bone metabolism other than osteoporosis
Documented pregnancy (see also 6.3)
Presence of implants not suited for MRI (pacemaker, neuro-stimulators, pain pumps, insulin pumps, Cochlea implants, metallic foreign bodies like bullet fragments)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georg Osterhoff, MD	Contact	0041 44 255 11 11		georg.osterhoff@usz.ch

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Trauma Surgery, University Hospital Zurich	Recruiting	Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016103	Spinal Fractures

Ancestor Terms

ID	Term
D013124	Spinal Injuries
D019567	Back Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided