Genetic Expression in Osteolysis, Infection, Arthrofibrosis & Metal Reactions in THA & TKA: A Microarray Analysis to Characterize Individual Host Response to the Molecular Mechanisms of Loosening and Arthrofibrosis

Overview

About this study

This study is being conducted to determine gene and protein expression profiles (i.e. which genes and proteins are turned off and on) of those with a possibility of developing osteolysis, infection, arthrofibrosis or metallosis of their THA/TKA.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. 200 patients undergoing primary THA/TKA for osteoarthritis.
    1. Adult (18 years old or greater)
    2. Primary diagnosis is osteoarthritis (OA)
    3. Must be primary total joint arthroplast  
  2. 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus aureus.
    1. Adult (18 years old or greater)
    2. Index surgical procedure was for OA 
    3. Patient must have metal-on-UHMWPE bearing surface
    4. At least 2 positive intraoperative cultures depicting Staphylococcus aureus
    5. Have clinical picture consistent with infection, including, but not limited to:
      1. Patient symptomatic
      2. Increased laboratory values (WBC, ESR, CRP)
      3. Positive aspiration
    6. Necessitates revision surgery in the opinion of the consulting surgeon
  3. 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus epidermidis.
    1. Adult (18 years old or greater)
    2. Index surgical procedure was for OA 
    3. Patient must have metal-on-UHMWPE bearing surface
    4. At least 2 positive intraoperative cultures depicting Staphylococcus epidermis
    5. Have clinical picture consistent with infection, including, but not limited to:
      1. Patient symptomatic
      2. Increased laboratory values (WBC, ESR, CRP)
      3. Positive aspiration
    6. Necessitates revision surgery in the opinion of the consulting surgeon
  4. 200 patients undergoing revision THA/TKA for culture negative infection.
    1. Adult (18 years old or greater)
    2. Index surgical procedure was for OA 
    3. Patient must have metal-on-UHMWPE bearing surface
    4. Negative cultures at time of surgery, but has one of following:
      1. Sinus tract (as determined by consulting surgeon)
      2. Gross purulence (as determined by consulting surgeon)
      3. Acute inflammation (as determined by consulting pathologist)
      4. Symptomatic patient with elevated inflammatory markers (WBC, CRP, ESR)
    5. Necessitates revision surgery in the opinion of the consulting surgeon
  5. 200 patients undergoing revision THA/TKA for culture negative osteolysis.
    1. Adult (18 years old or greater)
    2. Index surgical procedure was for OA 
    3. Patient must have metal-on-UHMWPE bearing surface
    4. Evidence of osteolysis on either serial plain radiographs (AP / cross-table lateral) or advanced imaging (CT or MRI with artifact minimization)
    5. Occurs in the absence of infection:
      1. Patient asymptomatic
      2. Normal laboratory values (WBC, ESR, CRP)
      3. Negative aspiration
      4. Negative cultures at time of surgery
    6. Necessitates revision surgery in the opinion of the consulting surgeon
  6. 100 patients undergoing revision THA for metal reaction.
    1. Adult (18 years old or greater)
    2. Index surgical procedure was for OA 
    3. Patient must have metal-on-metal bearing surface
    4. Soft tissue mass noted on MRI or US
    5. Periprosthetic pathologic tissue reveals chronic inflammation with perivascular lymphocytic aggregates
    6. Occurs in absence of infection:     
      1. Patient asymptomatic
      2. Normal laboratory values (WBC, ESR, CRP)
      3. Negative aspiration
      4. Negative cultures at time of surgery
    7. Necessitates revision surgery in the opinion of the consulting surgeon
  7. 100 patients undergoing revision TKA for flexion instability.
    1. Adult (18 years old or greater)
    2. Index surgical procedure was for OA 
    3. Patient must have metal-on-UHMWPE bearing surface
    4. Evidence of instability on either serial plain radiographs (AP / cross-table lateral) or advanced imaging (CT or MRI with artifact minimization)
    5. Occurs in the absence of infection:
      1. Patient asymptomatic
      2. Normal laboratory values (WBC, ESR, CRP)
      3. Negative aspiration
      4. Negative cultures at time of surgery
    6. Necessitates revision surgery in the opinion of the consulting surgeon
  8. 100 patients undergoing revision TKA for arthrofibrosis
    1. Adult (18 years old or greater)
    2. Index surgical procedure was for OA
    3. Patients must have metal-on-PE bearing surface
    4. Evidence of arthrofibrosis on clinical exam and/or plain radiographs
    5. Occurs in the absence of infection:
      1. Patient asymptomatic
      2. Normal laboratory values (WBC, ESR, CRP)
      3. Negative aspiration
      4. Negative cultures at time of surgery
    6. Necessitates revision surgery in the opinion of the consulting surgeon

Exclusion Criteria:

  1. 200 patients undergoing primary THA/TKA for osteoarthritis.
    1. Revision surgery
    2. Any diagnosis other than osteoarthritis (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
    3. History of malignancy in operative extremity
    4. Steroid use after index surgical procedure
    5. Presence of a condition interfering with the ability to provide informed consent
  2. 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus aureus.
    1. Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
    2. History of malignancy in operative extremity
    3. Steroid use after index surgical procedure
    4. Presence of a condition interfering with the ability to provide informed consent
  3. 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus epidermidis.
    1. Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
    2. History of malignancy in operative extremity
    3. Steroid use after index surgical procedure
    4. Presence of a condition interfering with the ability to provide informed consent
  4. 200 patients undergoing revision THA/TKA for culture negative infection.
    1. Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
    2. History of malignancy in operative extremity
    3. Steroid use after index surgical procedure
    4. Presence of a condition interfering with the ability to provide informed consent
  5. 200 patients undergoing revision THA/TKA for culture negative osteolysis.
    1. Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
    2. History of malignancy in operative extremity
    3. Steroid use after index surgical procedure
    4. Presence of a condition interfering with the ability to provide informed consent
  6. 100 patients undergoing revision THA for metal reaction.
    1. Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
    2. History of malignancy in operative extremity
    3. Steroid use after index surgical procedure
    4. Presence of a condition interfering with the ability to provide informed consent
  7. 100 patient undergoing revision TKA for instability.
    1. Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
    2. History of malignancy in operative extremity
    3. Steroid use after index surgical procedure
    4. Presence of a condition interfering with the ability to provide informed consent
  8. 100 patients undergoing revision TKA for arthrofibrosis
    1. Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e. inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.)
    2. History of malignancy in operative extremity
    3. Steroid use after index surgical procedure
    4. Presence of a condition interfering with the ability to provide informed consent

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Abdel, M.D.

Open for enrollment

Contact information:

Jessica Stutzman

(507)266-1227

Stutzman.Jessica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314933

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