Status:
UNKNOWN
Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Vejle Hospital
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients, both men and women, with anteromedial unicompartmental knee osteoarthritis
- Patients found suitable for UKA with telos stress-radiographs
- Patients with sufficient bone quality to allow insertion of a Uni Knee prosthesis
- Patellofemoral osteoarthritis is not a contraindication if the patient does not have symptoms from the patellofemoral joint
- Patients can only take part in one knee study
- All age groups, in good condition and responsible adults
- Informed, written compliance consent.
Exclusion
- Patients with neuromuscular or vascular diseases in the affected leg
- Patients found to be unsuitable for UKA before or at surgery
- Preoperative extensions defect greater than 10 degrees
- Preoperative maximal flection of less than 100 degrees
- Symptomatic patellofemoral osteoarthritis
- Insufficiency with regard to ACL
- Patients templated to a size XS or XL femoral component prior to surgery.
- Patients with osteoporosis on the basis of preoperative x-rays or earlier diagnosis
- Continuous medical treatment with vitamin K antagonist (Warfarin), known to reduce bone mass in general by a factor of 5
- Patients with fracture sequelae (intraarticular fracture and all tibial condyle fractures)
- Patients previous having PTO or other extensive knee surgery
- Patients with metabolic bone disease
- Patients with rheumatoid arthritis
- Postmenopausal female patients being treated with systemic hormonal substitution (not taking into local vaginal treatment)
- Patients who intermittently or continuously require treatment with systemic glucocorticoids
- Non-Danish citizens
- Insufficient command of the Danish language (read and speak)
- Senile dementia
- Misuse of drugs or Alcohol
- Serious psychiatric illness
- Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy
- Serious systemic disease (e.g.. hemiparesis and severe Parkinsonism)
- Systemic hip or back condition
- Employed by the department of orthopaedic surgery
- On-going case involving work injury of the knee
- Patients with poor dental status
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00679120
Start Date
May 1 2009
End Date
August 1 2024
Last Update
November 22 2023
Active Locations (1)
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1
Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8200