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

Conditions

• Complications; Arthroplasty
• Complications; Arthroplasty, Mechanical

Eligibility Criteria

Sex

ALL

Age

21 Years - 95 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Sep 15, 2017

Status verified

Jun 2024

Primary completion

May 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

240 participants (estimated)

Arms

• Arm: 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.)
• Arm: 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.)

Primary Outcome Measure

Utilize MRI to evaluate total hip arthroplasty designs traditionally not implicated with the presence of adverse local tissue reactions. [ Time Frame: An expected average of 1 year post-operatively ]

Central Contacts

• Matthew F Koff, PhD
  212-774-2103
  [email protected]
• Mauro Miranda, MFA
  212-774-1979
  [email protected]

Locations (1)

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