Last updated on February 2018

Prospective Clinical 5-year Follow-up of the LINK Endo-Model SL

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Osteonecrosis
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion criteria

  • Patients requiring TKA and therefore receiving the LINK Endo-Model SL. This includes patients who undergo revision surgery of prior knee arthroplasty after aseptic loosening, local infection, peri- or subprosthetic fracture or any other condition making revision of arthroplasty necessary as well as patients requiring primary arthroplasty with essential bone replacement.
  • Between 18 and 70 years of age.
  • Patient understands the conditions of the PMCF and is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and the prescribed postoperative management.
  • Patient has signed the Informed Consent Form.

Exclusion criteria

  • Body Mass Index (BMI) > 40 kg/m2
  • Poor general state of health
  • Knee replacement on the contralateral side within the last year and with an KSS outcome < 70 points
  • Patients with symptomatic OA of the hips, spine, ankles if it can interfere with the evaluation of the target knee
  • Any current treatment for malignancy or any malignancy treatment within the previous 2 years before the screening visit
  • Any clinically significant pathology based on clinical history that the investigator feels may affect the study evaluation
  • Any intercurrent chronic disease or condition that may interfere with the completion of the 5- year follow-up, such as liver disease, sever coronary disease, drug abuse, disordered mental state, or other clinically significant condition
  • Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
  • Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
  • Patients with systemic or metabolic disorders leading to progressive bone deterioration
  • Patients who have a medical condition with less than 5 years of life expectancy
  • Current alcoholism and/or any known current addiction to pain medication or drugs
  • Previous organ transplantation
  • Any psychiatric illness that would prevent comprehension of the details and nature of the study
  • Participation in any experimental drug/device study within 6 months prior to the screening visit
  • Patients with ulceration of the lower extremities e.g. in diabetic foot syndrome
  • Acute or chronic floride infections, local and systemic
  • Revision in floride septic environment
  • Allergy or intolerance to any device material
  • Recurrent medical history of severe allergic reactions
  • Foreign body sensitivity
  • Distinctive muscular, nerve, vascular or other diseases which put the affected limb at risk
  • Insufficient bone integrity which prevents a stable anchorage of the prosthesis
  • Female patient who is pregnant or plans to become pregnant during the course of the investigation
  • Prisoner
  • Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule
  • Patient who has not signed the Informed Consent

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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