Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types

Launched by UNIVERSITY OF AARHUS · May 15, 2008

Keywords

ClinConnect Summary

The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a series of three different Oxford Uni Knees by studying:

1. Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed).
2. Fluoroscopy (screening) roentgeno...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients, both men and women, with anteromedial unicompartmental knee osteoarthritis
• • 2. Patients found suitable for UKA with telos stress-radiographs
• • 3. Patients with sufficient bone quality to allow insertion of a Uni Knee prosthesis
• • 4. Patellofemoral osteoarthritis is not a contraindication if the patient does not have symptoms from the patellofemoral joint
• • 5. Patients can only take part in one knee study
• • 6. All age groups, in good condition and responsible adults
• • 7. Informed, written compliance consent.
• Exclusion Criteria:
• • 1. Patients with neuromuscular or vascular diseases in the affected leg
• • 2. Patients found to be unsuitable for UKA before or at surgery
• • 3. Preoperative extensions defect greater than 10 degrees
• • 4. Preoperative maximal flection of less than 100 degrees
• • 5. Symptomatic patellofemoral osteoarthritis
• • 6. Insufficiency with regard to ACL
• • 7. Patients templated to a size XS or XL femoral component prior to surgery.
• • 8. Patients with osteoporosis on the basis of preoperative x-rays or earlier diagnosis
• • 9. Continuous medical treatment with vitamin K antagonist (Warfarin), known to reduce bone mass in general by a factor of 5
• • 10. Patients with fracture sequelae (intraarticular fracture and all tibial condyle fractures)
• • 11. Patients previous having PTO or other extensive knee surgery
• • 12. Patients with metabolic bone disease
• • 13. Patients with rheumatoid arthritis
• • 14. Postmenopausal female patients being treated with systemic hormonal substitution (not taking into local vaginal treatment)
• • 15. Patients who intermittently or continuously require treatment with systemic glucocorticoids
• • 16. Non-Danish citizens
• • 17. Insufficient command of the Danish language (read and speak)
• • 18. Senile dementia
• • 19. Misuse of drugs or Alcohol
• • 20. Serious psychiatric illness
• • 21. Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy
• • 22. Serious systemic disease (e.g.. hemiparesis and severe Parkinsonism)
• • 23. Systemic hip or back condition
• • 24. Employed by the department of orthopaedic surgery
• • 25. On-going case involving work injury of the knee
• • 26. Patients with poor dental status