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

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria - 200 patients undergoing primary THA/TKA for osteoarthritis:

  • Adult (18 years old or greater).
  • Primary diagnosis is osteoarthritis (OA).
  • Must be primary total joint arthroplast  .

Inclusion Criteria - 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus aureus:

  • Adult (18 years old or greater).
  • Index surgical procedure was for OA .
  • Patient must have metal-on-UHMWPE bearing surface.
  • At least 2 positive intraoperative cultures depicting Staphylococcus aureus.
  • Have clinical picture consistent with infection, including, but not limited to:
    • Patient symptomatic;
    • Increased laboratory values (WBC, ESR, CRP);
    • Positive aspiration;
    • Necessitates revision surgery in the opinion of the consulting surgeon.

Inclusion Criteria - 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus epidermidis:

  • Adult (18 years old or greater).
  • Index surgical procedure was for OA .
  • Patient must have metal-on-UHMWPE bearing surface.
  • At least 2 positive intraoperative cultures depicting Staphylococcus epidermis.
  • Have clinical picture consistent with infection, including, but not limited to:
    • Patient symptomatic;
    • Increased laboratory values (WBC, ESR, CRP);
    • Positive aspiration;
    • Necessitates revision surgery in the opinion of the consulting surgeon.Inc

Inclusion Criteria - 200 patients undergoing revision THA/TKA for culture negative infection:

  • Adult (18 years old or greater).
  • Index surgical procedure was for OA .
  • Patient must have metal-on-UHMWPE bearing surface.
  • Negative cultures at time of surgery, but has one of following:
    • Sinus tract (as determined by consulting surgeon);
    • Gross purulence (as determined by consulting surgeon);
    • Acute inflammation (as determined by consulting pathologist);
    • Symptomatic patient with elevated inflammatory markers (WBC, CRP, ESR);
    • Necessitates revision surgery in the opinion of the consulting surgeon.

Inclusion Criteria - 200 patients undergoing revision THA/TKA for culture negative osteolysis:

  • Adult (18 years old or greater).
  • Index surgical procedure was for OA .
  • Patient must have metal-on-UHMWPE bearing surface.
  • Evidence of osteolysis on either serial plain radiographs (AP / cross-table lateral) or advanced imaging (CT or MRI with artifact minimization).
  • Occurs in the absence of infection:
    • Patient asymptomatic;
    • Normal laboratory values (WBC, ESR, CRP);
    • Negative aspiration;
    • Negative cultures at time of surgery;
    • Necessitates revision surgery in the opinion of the consulting surgeon.
  • 100 patients undergoing revision THA for metal reaction.
  • Adult (18 years old or greater).
  • Index surgical procedure was for OA .
  • Patient must have metal-on-metal bearing surface.
  • Soft tissue mass noted on MRI or US.
  • Periprosthetic pathologic tissue reveals chronic inflammation with perivascular lymphocytic aggregates.
  • Occurs in absence of infection:     
    • Patient asymptomatic;
    • Normal laboratory values (WBC, ESR, CRP);
    • Negative aspiration;
    • Negative cultures at time of surgery;
    • Necessitates revision surgery in the opinion of the consulting surgeon.

Inclusion Criteria - 100 patients undergoing revision TKA for flexion instability:

  • Adult (18 years old or greater).
  • Index surgical procedure was for OA .
  • Patient must have metal-on-UHMWPE bearing surface.
  • Evidence of instability on either serial plain radiographs (AP / cross-table lateral) or advanced imaging (CT or MRI with artifact minimization).
  • Occurs in the absence of infection:
    • Patient asymptomatic;
    • Normal laboratory values (WBC, ESR, CRP);
    • Negative aspiration;
    • Negative cultures at time of surgery;
    • Necessitates revision surgery in the opinion of the consulting surgeon.

Inclusion Criteria - 100 patients undergoing revision TKA for arthrofibrosis:

  • Adult (18 years old or greater).
  • Index surgical procedure was for OA.
  • Patients must have metal-on-PE bearing surface.
  • Evidence of arthrofibrosis on clinical exam and/or plain radiographs.
  • Occurs in the absence of infection:
    • Patient asymptomatic;
  • Normal laboratory values (WBC, ESR, CRP);
  • Negative aspiration;
  • Negative cultures at time of surgery;
  • Necessitates revision surgery in the opinion of the consulting surgeon.

Exclusion Criteria - 200 patients undergoing primary THA/TKA for osteoarthritis:

  • Revision surgery.
  • History of malignancy in operative extremity.
  • Steroid use after index surgical procedure.
  • Presence of a condition interfering with the ability to provide informed consent.

Exclusion Criteria - 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus aureus:

  • Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e., inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.).
  • History of malignancy in operative extremity.
  • Steroid use after index surgical procedure.
  • Presence of a condition interfering with the ability to provide informed consent.

Exclusion Criteria - 200 patients undergoing revision THA/TKA for infection with culture positive Staphylococcus epidermidis:

  • Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e., inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) .
  • History of malignancy in operative extremity.
  • Steroid use after index surgical procedure.
  • Presence of a condition interfering with the ability to provide informed consent.

Exclusion Criteria - 200 patients undergoing revision THA/TKA for culture negative infection:

  • Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e., inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) 
  • History of malignancy in operative extremity
  • Steroid use after index surgical procedure
  • Presence of a condition interfering with the ability to provide informed consent.

Exclusion Criteria - 200 patients undergoing revision THA/TKA for culture negative osteolysis:

  • Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e., inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) .
  • History of malignancy in operative extremity.
  • Steroid use after index surgical procedure.
  • Presence of a condition interfering with the ability to provide informed consent.

Exclusion Criteria - 100 patients undergoing revision THA for metal reaction:

  • Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e., inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.) .
  • History of malignancy in operative extremity.
  • Steroid use after index surgical procedure.
  • Presence of a condition interfering with the ability to provide informed consent.

Exclusion Criteria - 100 patient undergoing revision TKA for instability:

  • Any diagnosis other than osteoarthritis as reason for index surgical procedure (i.e., inflammatory arthritis, posttraumatic arthritis, septic arthritis, osteonecrosis, etc.).
  • History of malignancy in operative extremity.
  • Steroid use after index surgical procedure.
  • Presence of a condition interfering with the ability to provide informed consent.

Exclusion Criteria - 100 patients undergoing revision TKA for arthrofibrosis:

  • History of malignancy in operative extremity.
  • Steroid use after index surgical procedure.
  • Presence of a condition interfering with the ability to provide informed consent.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Abdel, M.D.

Abierto para la inscripción

Contact information:

Lauren Cole

(507) 266-1227

Cole.Lauren@mayo.edu

More information

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