total knee replacement
Conditions
Interventions
None listed
Sponsors
Stryker Howmedica
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form.;2) The subject is a male or non-pregnant female between 40 and 75 years of age.;3) The subject requires a primary total knee replacement.;4) Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis);5) The subject has intact collateral ligaments.;6) The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.;7) The subject is capable of understanding the patient scores in the national language.
Exclusion criteria
Exclusion criteria: 1) The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.;2) The subject has a history of total or unicompartmental reconstruction of the affected joint.;3) The subject will be operated bilaterally.;4) Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).;5) Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).;6) Patients who will need lower limb joint replacement for another joint within one year. 7) The subject has had a high tibial osteotomy or femoral osteotomy.;8) The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.;9) The subject has a systemic or metabolic disorder leading to progressive bone deterioration.;10) The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.;11) The subject*s bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.;12) The subject has had a knee fusion to the affected joint.;13) The subject has an active or suspected latent infection in or about the knee joint.;14) Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition).;15) Female patients planning a pregnancy during the course of the study.;16) The subject is a prisoner.;17) severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur > 20 degree, as well as 10 degrees flexion contracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. clinical evaluation: preoperative, peri-oprative, potopreative prior to discharge and follow-up 2. patient scores: KOOS (Knee injury and osteoarthritis outcome score) and SF-36 for patient satisfaction LEAS (Lower Extemety Activity Scale) for patient activity EQ5D (Quality of Life) | — |
Secondary
| Measure | Time frame |
|---|---|
| see primary parameters | — |
Countries
Netherlands
Outcome results
None listed