Clinical trial NCT02255331: Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
Official title: The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complications; Arthroplasty
Complications; Arthroplasty, Mechanical
Keywords: Arthroplasty
Replacement
Hip
MRI
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2014-10-02
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who will be having revision surgery of a total hip replacement, or individuals who currently have a total hip replacement with uncemented components.

Brief summary: Patients with a total hip replacement may require early revision surgery due to an adverse local tissue reaction or bone resorption that occurs due to wear debris released from the implant. MRI provides a non-invasive biomarker for clinicians and surgeons to detect early adverse synovial reactions which may exist in the absence of clinical symptoms, thus imparting essential information for clinical management. This study will address two of the most commons causes of hip implant failure, including adverse local tissue reaction in implants not traditionally associated with adverse tissue reactions, as well as the presence of aseptic loosening and loss of implant-bone integration.

Detailed description: Total hip arthroplasty (THA) has been successful in achieving pain reduction, but recent concerns have been raised regarding the development of adverse local tissue reactions (ALTRs). Our group has previously found that: 1) Magnetic resonance imaging (MRI) can detect and distinguish wear debris from THA; 2) MRI is sensitive to ALTR damage from different articulating surfaces; and 3) variable host-mediated response to wear debris mounts distinct morphologic patterns on MRI. There is continued interest in the evaluation of soft tissues near THAs as traditional THA designs, including metal-on-polyethylene (MOP) and ceramic-on-polyethylene (COP) bearing surfaces, have recently been implicated in ALTRs. It is believed that fretting and corrosion at the head-neck junction is responsible for ALTRs, secondary to flexural rigidity and other implant mechanical features. If a greater prevalence of ALTR is found in components with more flexible connections, this could drive the practice of THA to stiffer connections.

In this study, we will evaluate two important causes of implant failure: (1) in designs not traditionally associated with ALTRs such as metal-on-polyethylene (MOP) and ceramic-on-polyethylene (COP) we will assess patients indicated for revision THA surgery with MRI and correlate the imaging metrics to targeted biopsy retrieval obtained at the time of revision (including the trunnion), the extent of tissue damage documented at surgery, and implant retrieval analysis of the neck trunnion, including flexural rigidity analysis; and (2) to longitudinally assess implant integration using qualitative MRI evaluation of the bone-implant interface as well as quantitative MRI techniques, T2 mapping and T2\* mapping using MAVRIC-UTE, to evaluate relaxometry at the interface.

Eligibility criteria: Inclusion Criteria:

Cohort #1:

1. Have a total hip replacement with a ceramic component undergoing revision for any reason, including recurrent dislocation.
2. Have a metal-on-polyethylene total hip replacement and have repeated dislocation, or
3. Have a metal-on-polyethylene total hip replacement greater than 1 year old, or
4. Have an infected total hip replacement (any surface bearing)

Cohort #2:

1. Have a total hip replacement with a ceramic component.
2. Have a metal-on-polyethylene total hip replacement.
3. Have your original or revised total hip replacement.

Exclusion Criteria:

Cohort #1:

1. Have occupational exposure to cobalt or chromium
2. Presence of MOM or recalled implant
3. Have had a prior revision of your total hip
4. Standard contra-indications to MRI

Cohort #2:

1. Have occupational exposure to cobalt or chromium.
2. Have cemented components.
3. Presence of a metal-on-metal or recalled implant.
4. Standard contra-indications to MRI.

Primary outcomes:
measure: Utilize MRI to evaluate total hip arthroplasty designs traditionally not implicated with the presence of adverse local tissue reactions.
timeFrame: An expected average of 1 year post-operatively
measure: Longitudinal monitor of arthroplasty loosening in patients with different individual risk factors and implant bearing surfaces and characteristics
timeFrame: This outcome will be measured at 4 different time points: Initial office visit, 1 year follow-up, 2 year follow-up, 3 year follow-up.
Secondary outcomes:
measure: Mode of total hip arthroplasty failure
timeFrame: An expected average of 1 year post-operatively
measure: Blood serum metal ion levels
timeFrame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit, 1 year follow-up, 2 year follow-up, and 3 year follow-up for individuals being monitored longitudinally.
measure: Radiographic evaluation of implant orientation - anteversion and inclination
timeFrame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit for individuals being monitored longitudinally.
measure: MRI evaluation of soft tissues surrounding total hip arthroplasty
timeFrame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit, 1 year follow-up, 2 year follow-up, and 3 year follow-up for individuals being monitored longitudinally.
measure: Intraoperative damage assessment
timeFrame: Measurement during revision surgery for total hip arthroplasty patients
measure: Histologic analysis of retrieved tissues
timeFrame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
measure: Implant retrieval wear analysis
timeFrame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
measure: T2 Mapping of synovial tissues
timeFrame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Matthew F Koff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Hollis G Potter, MD
role: PRINCIPAL_INVESTIGATOR
References: