MARS MRI in Revision THA With a Ceramic Femoral Head and... | NCT05686915

Studies
MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve

NCT05686915

Sponsor

Colorado Joint Replacement

Status

Unknown status

Last Update Posted

Jan 17, 2023Actual

Enrollment

55Estimated

Phase

Not provided

Conditions

Arthroplasty, Replacement, Hip

Interventions

MARS MRI
Titanium Labs
Cobalt Labs
Chromium Labs

Countries

United States

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

Jan 2023

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 22, 2022Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jan 6, 2023

First Submission Date that Met QC Criteria

Jan 13, 2023

First Posted Date

Jan 17, 2023Actual

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

Jan 13, 2023

Last Update Posted Date

Jan 17, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jason Jennings, Orthopedic Surgeon, Colorado Joint ReplacementPrincipal Investigator

Lead Sponsor

Colorado Joint ReplacementOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.

Detailed Description

Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Revision Total Hip Arthroplasty		Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve	Diagnostic Test: MARS MRI Diagnostic Test: Titanium Labs Diagnostic Test: Cobalt Labs Diagnostic Test: Chromium Labs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MARS MRI	Diagnostic Test	metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities	Revision Total Hip Arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MARS MRI abnormalities	Local Tissue Reactions or Fluid collections on the MARS MRI Scan	2 Years Post Revision Total Hip Replacement

Secondary Outcomes

Measure	Description	Time Frame
Titanium Lab Value	Titanium levels in blood	2 Years Post Revision Total Hip Replacement
Chromium Lab Value	Chromium levels in blood

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
Patient whose age ranges from 18-99
Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip
Patients who are at least 2 years after a revision THA
Acetabular implant (cup) was placed in the appropriate position
Patients with a Harris Hip Score of >90

Exclusion Criteria:

Patients who do not meet the above criteria
Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roseann M Johnson, BS, CCRP	Contact	303-260-2940		roseannjohnson@centura.org

Overall Officials

Name	Affiliation	Role
Jason M Jennings, MD	Colorado Joint Replacement	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Colorado Joint Replacement	Recruiting	Denver	Colorado	80210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25141843	Background	Fehring TK, Fehring K, Odum SM. Metal artifact reduction sequence MRI abnormalities occur in metal-on-polyethylene hips. Clin Orthop Relat Res. 2015 Feb;473(2):574-80. doi: 10.1007/s11999-014-3873-6.