revision total knee arthroplasty
Conditions
Interventions
The trial treatments are cemented or press-fit implantation of the tibial and femoral stems of the Revision total knee arthroplasty and associated hospital preoperative, per-operative and postoperativ
Sponsors
Sint Maartenskliniek, Nijmegen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is sceduled for revision total knee arthroplasty. 2. Both cemented and press-fit placed stems are indicated. 3. Patient plans to be available for follow-up through five years post-operative. 4. Patient is in stable health and free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive surgical risk. 5. Patient is willing to consent and participate in the study by signing and dating and IRB-approved consent form.
Exclusion criteria
Exclusion criteria: 1. Radiologically (or per-operatively) defined Type III bone loss according to the Anderson Orthopaedic Research Institute Bone stock Classification. 2. BMI > 35. 3. Acitve, or local infection or systemic infection. 4. Patient has physical, emotional or neurological conditions that would compromise the patient’s compliance with postoperative rehabilitation protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple Sclerosis, etc.). 5. Patient has an immunosuppressive disorder (chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli). Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients with acquired immunodeficiency syndrome (AIDS) or auto-immune diseases (including inflammatory arthritis). 6. Patient has a known sensitivity to materials in the device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the stability of the prosthesis, measured with RSA. Stability is defined as migration (mm) and rotation (degrees) of the tibia and femurcomponent in all degrees of freedom. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Peri-operative data (blood loss, surgery duration) - Knee Society Score - KOOS - VAS pain and VAS satisfaction - Active and passive flexion. | — |
Contacts
Public ContactHenriëtte Gouw, de
Sint Maartenskliniek Hengstdal 3
Outcome results
None listed