Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity

Complications; Arthroplasty Clinical Trial

Official title:

The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02255331
• Other study ID #: 2015-442 R01 AR064840
• Status: Recruiting
• Start date: September 15, 2017
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Hospital for Special Surgery, New York
• Contact: Matthew F Koff, PhD
• Phone: 212-774-2103
• Email: koffm[@]hss.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complications; Arthroplasty
• Complications; Arthroplasty, Mechanical

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilize MRI to evaluate total hip arthroplasty designs traditionally not implicated with the presence of adverse local tissue reactions.	All enrolled arthroplasty designs will be evaluated utilizing the input of: Evaluation of MR images: Presence, location, type and volume of synovitis, Synovial thickness, Impression of synovium, Presence and location of decompression of synovitis, Presence and location of low signal intensity deposits, Presence of soft tissue edema, Presence and location of dehiscence, Presence, location and volume of osteolysis, Assessment of implant loosening, Presence of and location of neurovascular compression, Disruption of abductors due to distended pseudocapsule, Presence of enlarged lymph nodes and presence and grading of adverse local tissue reaction.; Pre-operative blood metal ion levels; Pre-operative Hip disability and Osteoarthritis Outcome Score; Pathologic evaluation of tissue obtained intra-operatively; Intra-operative grade of soft tissues around the primary total hip replacement; Implant wear analysis	An expected average of 1 year post-operatively
Primary	Longitudinal monitor of arthroplasty loosening in patients with different individual risk factors and implant bearing surfaces and characteristics	All enrolled arthroplasty designs will be evaluated utilizing the input of: The formation a fibrous membrane and/or osteolysis around the implants; Individual risk factors from subjects (gender, BMI, primary diagnosis, and level of activity); Individual risk factors based on implant characteristics (stem length, head size, and modular stem connections).	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	Mode of total hip arthroplasty failure	Patients will be classified as symptomatic with mechanical symptoms and symptomatic with unexplained pain. These groups are based on the categories used by the National Joint Registry of England and Wales. Patients presenting with loosening, instability, or malalignment will be classified as "mechanical" failure. In cases of loosening, patients will be categorized as having acetabular or femoral loosening, only when documented intra-operatively by the surgeon. Patients presenting with pain not attributable to implant loosening, instability, or component malposition will be classified as "unexplained" failure. No specific unit of measure will be used for this outcome measure.	An expected average of 1 year post-operatively
Secondary	Blood serum metal ion levels	Blood samples will be drawn into lithium-heparin containing tubes with non-contamination precautions, and analyzed with high resolution inductively coupled mass spectrometry for the most accurate assessment of Cobalt and Chromium metal ion levels, to be measured in parts per million (ppm) or microgram per liter (ug/L)	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.
Secondary	Radiographic evaluation of implant orientation - anteversion and inclination	The assessment of hip replacement acetabular component position will be performed using the Einzel-Bild-Roentgen-Analysis (EBRA) software. The femoral stem-shaft angle will be measured in the frontal plane. The acetabular inclination angle will be measured in the frontal plane. The acetabular anteversion angle will be measured in the lateral plane. All measurements will be expressed in units of degrees.	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.
Secondary	MRI evaluation of soft tissues surrounding total hip arthroplasty	Evaluation of MR images: Presence, location, type and volume (measurement units of mm^3) of synovitis, Synovial thickness (measurement units of mm), Impression of synovium, Decompression of synovitis, Decompression into Trochanteric Bursa, Decompression into Iliopsoas, Presence and location of low signal intensity deposits, Presence of soft tissue edema, Presence and location of dehiscence, Presence, location and volume (measurement units of mm^3) of osteolysis, Assessment of implant loosening, Presence of and location of neurovascular compression, Disruption of abductors due to distended pseudocapsule, Presence of enlarged lymph nodes and presence and grading of adverse local tissue reaction. All quantitative values have the units of measurement indicated.	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.
Secondary	Intraoperative damage assessment	A subjective scoring system will be used for intraoperative damage assessment of the hip joint. The system is based on a 0 to 3 scale denoting the level of involvement of the soft tissues surrounding the joint (capsule, synovium, and muscle): 0 = Normal tissue; 1 = Fluid collection ± mild synovial reaction with or capsular dehiscence; 2 = the same findings as a score of 1, but with moderate synovial reaction; and 3 = the same findings as a score of 2, but with the addition of damage to the abductor muscle and/or osteolysis. No specific unit of measure will be used for this outcome measure.	Measurement during revision surgery for total hip arthroplasty patients
Secondary	Histologic analysis of retrieved tissues	Histological evaluation will be using a 10 point aseptic lymphocytic vasculitis associated lesion (ALVAL) score to assess tissue reaction to a total hip replacement. The ALVAL score is a summation of individual grades assigned to the integrity of the synovial lining, presence and extent of inflammatory cell infiltrates, necrosis and tissue organization.; We will use a supplemental grading system intended for metal-on-poly and ceramic implants since ALVAL grading is used primarily for metal-on-metal (MOM) articulations and may not detect similar features of wear debris in non-MOM articulations, polyethylene, metal or corrosion products. The presence of ceramic and polyethylene particles and the relative number of macrophages, giant cells, histiocytes, acute or chronic inflammatory cells, and presence of necrotic tissue will be graded using the scale of: 1) absent (-), little (+), moderate (++), extensive (+++). No specific unit of measure will be used for this outcome measure.	Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
Secondary	Implant retrieval wear analysis	The bearing surfaces of the femoral heads and acetabular components, the neck trunnion of the total hip replacement femoral stems, and the matching female tapers of the total hip replacement heads retrieved at surgery will be scanned with a technique that utilizes a non-contact measurement method to calculate volumetric wear (measurement units of mm^3) and linear wear (measurement units of mm).	Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
Secondary	T2 Mapping of synovial tissues	Quantitative imaging, specifically T2 mapping of soft tissues near the implant, specifically, the synovium and synovial volume.	Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.

External Links

•   Hospital for Special Surgery MRI Laboratory