Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT00679120
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00679120
Study Brief:
Protocol Section:
NCT00679120