In the present study we evaluate the change in quality of cartilage and bone as a result of KJD and of HTO. Based on the results of this pilot study, we will design a clinical study, with sufficient power, using the most promising sequences to…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following parameters will be compared between pre-, 1 year, and 2 years
post treatment for KJD and pre- and 2 years post treatment for HTO:
1. the change in cartilage *proteoglycan content*
2. the change in *collagen content/distribution*
3. the change in *bone marrow lesions*
4. the change in *3D bone density*
And secondary:
1. is there a mutual relation between quantitative cartilage and bone changes
2. is there a relation between qualitative cartilage and bone changes with
those of quantitative changes in the cartilage as measured in the original RCTs.
3. is there a relation of (combinations of) changes in qualitative and
quantitative parameters of bone and cartilage to clinical benefit of KJD and
HTO
Secondary outcome
n.a.
Background summary
Cartilage and bone changes induced by knee joint distraction, and more recently
suggested to occur by osteotomy as well, is difficult to evaluate objectively.
There are only surrogate markers like sophisticated MRI and CT analyses for
evaluating cartilage and bone quality. Recently two prospective trials
randomising a total knee prosthesis (TKP), with knee joint distraction (KJD),
and randomising high tibial osteotomy (HTO) with KJD were started, evaluating
clinical benefit and quantitative cartilage changes.
Study objective
In the present study we evaluate the change in quality of cartilage and bone as
a result of KJD and of HTO. Based on the results of this pilot study, we will
design a clinical study, with sufficient power, using the most promising
sequences to evaluate cartilage and bone changes accurately after treatment.
Study design
This is a 2 year follow-up observational pilot study.
Study burden and risks
There is no direct benefit for the patients when participating in this pilot
study. By participating in the study, patients contribute to further valuable
developments in knowledge on joint tissue repair by use of surrogate imaging
markers for cartilage and bone quality characteristics in general and
specifically due to KJD and to HTO. All proposed imaging techniques are already
used in clinical practice.
The risk for patients is minimal; there is a negligible risk due to x-ray
radiation and a minimal risk due to use of intra venous contrast agent.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38442.041.11 |