The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. This will be done by collecting information on: * removal of any metal components of the hip or knee implants used in combination with the cement * frequency and incidence of adverse events * overall pain and functional performance, subject quality of life, and radiographic parameters
Multicenter, retrospective and prospective, non-controlled Post-Market Clinical Follow-Up (PMCF) study involving orthopedic surgeons skilled in knee or hip arthroplasty procedures. Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.
Study Type
OBSERVATIONAL
Hip or knee revision surgery resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains.
Diakonessenhuis UMC Utrecht
Utrecht, Netherlands
Survivorship
* removal of any metal components of the hip or knee implants used in combination with the cement * frequency and incidence of adverse events
Time frame: 3, 5 and 10 years post-operatively
EuroQuol 5D (EQ-5D) Score
Subject quality of life assessed through the completion of an EQ-5D questionnaire, when available
Time frame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Harris Hip Score / Knee Society Score
Pain and functional performance assessed through the completion of an Harris Hips Score (HHS) or Knee Society Score (KSS) questionnaires, when available, depending on whether the revision procedure was performed on hip or knee
Time frame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Radiographic evaluation
Radiographic evaluation, when available, include but is not limited to: radiolucency, cement mantle, osteolysis, atrophy, hypertrophy, migration/subsidence and heterotopic ossification.
Time frame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
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