failure primary total knee prosthesis osteoartritis
Conditions
Interventions
In patients of the first group the stems of the prosthesis will be cemented, in
the other group the stems will be placed press-fit.
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - patient requires a revision of his primary total knee replacement and the Legion system with both experimental implantation techniques is indicated in this patient. - patients is willing to consent to participate in the study by signing and dating an IRB-approved consent form. - patient plans to be available for follow-up through five years postoperative. - patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk. - patient has radiologically defined Type I or Type IIa/b bone loss according to Anderson Orthopedic Research Institute Bonestock Classification.
Exclusion criteria
Exclusion criteria: - patient has radiologically or per-operatively defined Type III bone loss according to Anderson Orthopedic Research Institute Bonestock Classification. - patient has a BMI>35. - patient has an active, local infection or systemic infection. - patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up. - patient has an immunosuppressive disorder (chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli). - patient has a known sensitivity to materials in the device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary researchparameter is stability of the prosthesis measured with RSA, expressed in migration of the prosthesis components. | — |
Secondary
| Measure | Time frame |
|---|---|
| Peri-operative data (operative time, blood loss), Knee Society Score, active flexion, passive range of motion, VAS pain and VAS satisfaction. | — |
Countries
Netherlands
Outcome results
None listed