Qualitative imaging of cartilage and bone in end stage knee osteoarthritis treated with knee joint distraction or high tibial osteotomy.
Completed
- Conditions
- joint degenerationosteoarthritis10023213
- Registration Number
- NL-OMON39812
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
Inclusion Criteria
Patients randomized to Knee joint distraction or High tibial osteotomy in either of the two recently started trials.
Exclusion Criteria
Patients with risks due to the magnetic field of the MRI such as those with pacemakers, nerve stimulators, metal implants, stents, clips, etc
Patients with a known anaphylactic reaction to gadolinium or related substances
Patients with (a history of) kidney disease or with a kidney transplantation
Patients with a glomerular filtrationrate of <60 ml/min/1,73m2
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The following parameters will be compared between pre-, 1 year, and 2 years<br /><br>post treatment for KJD and pre- and 2 years post treatment for HTO:<br /><br>1. the change in cartilage *proteoglycan content*<br /><br>2. the change in *collagen content/distribution*<br /><br>3. the change in *bone marrow lesions*<br /><br>4. the change in *3D bone density*<br /><br><br /><br>And secondary:<br /><br>1. is there a mutual relation between quantitative cartilage and bone changes<br /><br>2. is there a relation between qualitative cartilage and bone changes with<br /><br>those of quantitative changes in the cartilage as measured in the original RCTs.<br /><br>3. is there a relation of (combinations of) changes in qualitative and<br /><br>quantitative parameters of bone and cartilage to clinical benefit of KJD and<br /><br>HTO</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>