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

NCT02255331 | Recruiting

• 1 other identifier: 2015-442 R01 AR064840
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Arthroplasty; Complications; Arthroplasty, Mechanical

Keywords

Arthroplasty; Replacement; Hip; MRI

Outcome Measures

Primary Outcomes (2)

• 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: 1. 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. 2. Pre-operative blood metal ion levels 3. Pre-operative Hip disability and Osteoarthritis Outcome Score 4. Pathologic evaluation of tissue obtained intra-operatively 5. Intra-operative grade of soft tissues around the primary total hip replacement 6. Implant wear analysis

  An expected average of 1 year post-operatively

• 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: 1. The formation a fibrous membrane and/or osteolysis around the implants 2. Individual risk factors from subjects (gender, BMI, primary diagnosis, and level of activity) 3. 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 Outcomes (8)

• Mode of total hip arthroplasty failure

  An expected average of 1 year post-operatively

• Blood serum metal ion levels

  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.

• Radiographic evaluation of implant orientation - anteversion and inclination

  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.

• MRI evaluation of soft tissues surrounding total hip arthroplasty

  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.

• Intraoperative damage assessment

  Measurement during revision surgery for total hip arthroplasty patients

Study Arms (2)

Retrieval Analysis

You qualify for this Retrieval Analysis study if you: 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) You do not qualify for this arm of the study if you: 1. Have occupational exposure to cobalt or chromium 2. Presence of a metal-on-metal (MOM) implant, or a recalled implant 3. Have had a prior revision of your total hip 4. Standard contra-indications to MRI (e.g. cardiac pacemaker, etc.)

Longitudinal Evaluation

You qualify for this arm of the study if you: 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. You do not qualify for this arm of the study if you: 1. Have occupational exposure to cobalt or chromium 2. Have cemented components. 3. Presence of a metal-on-metal (MOM) implant, or a recalled implant 4. Standard contra-indications to MRI (e.g. cardiac pacemaker, etc.)

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Cohort #1:
• Have occupational exposure to cobalt or chromium
• Presence of MOM or recalled implant
• Have had a prior revision of your total hip
• Standard contra-indications to MRI
• Cohort #2:
• Have occupational exposure to cobalt or chromium.
• Have cemented components.
• Presence of a metal-on-metal or recalled implant.
• Standard contra-indications to MRI.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Medical College of Wisconsin: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Links

• Hospital for Special Surgery MRI Laboratory

Biospecimen

Retention: SAMPLES WITHOUT DNA

1\. A small sample of soft tissues surrounding a total hip replacement will be retained for histological evaluation

Study Officials

• Matthew F Koff, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

• Hollis G Potter, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew F Koff, PhD

CONTACT

212-774-2103; koffm@hss.edu

Mauro Miranda, MFA

CONTACT

212-774-1979; mirandam@hss.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: October 2, 2014
• Study Start: September 15, 2017
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available within 1 year of study completion
• Access Criteria: Data access requests will be reviewed by the primary investigators

Locations

US (1)