1. To compare cartilage repair between KJD and HTO, evaluated 2 years post treatment. The hypothesis is that KJD results in (more) cartilage repair compared to HTO. 2. To compare cartilage tissue repair over 2 year follow-up compared to baseline and…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Intrinsic cartilage repair, examined as decrease in 'denuded area's of
bone', as determined on quantitative MRI in comparison with own baseline values
and with HTO.
Secondary outcome
2. Cartilage tissue repair over 2 year follow-up compared to baseline by use of
queantitative MRI parameters of the same iamges, X-ray evaluation, and
biomarker analyses in blood and urine.
3. Clinical effetiveness determined by a questionnaire for pain, other
symptoms, function in daily living, function in sports and recreation, and knee
related quality of life (KOOS) and a VAS for pain.
4. Indication of costs-effeciveness.
Background summary
Knee Joint Distraction (KJD) is proven to be beneficial in patients with
endstage osteoarthritis of the knee in comparison with their own baseline
profile. Following, this experimental procedure will be compared with currently
used surgical techniques in treatment of osteoarthritis of the knee, namely
high tibial osteotomy (HTO). It is expected that KJD result in (more) intrinsic
cartilage repair and has equivalently or better clinical outcome.
Study objective
1. To compare cartilage repair between KJD and HTO, evaluated 2 years post
treatment. The hypothesis is that KJD results in (more) cartilage repair
compared to HTO.
2. To compare cartilage tissue repair over 2 year follow-up compared to
baseline and between treatments by use of (additional) quantitative MRI
parameters of the same images, as well as X-ray evaluation, and analyses of
serum and urine biochemical markers of cartilage turnover.
3. To describe and compare the clinical efficacy over 2 years of treatment by a
questionnaire (KOOS; for pain, other symptoms, function in daily living,
function in sports and recreation, and knee related quality of life) and by a
VAS for pain.
4. To gather preliminary data on medical consumption and non-medical costs
related to disease and treatment as well as quality of life.
Study design
This, single site, randomised controlled, unblinded 2 years follow-up trial
will be accomplished at the Maartenskliniek Woerden (MK-W). Patients with
severe unicompartimental OA of the knee, for whom conservative therapy fails
and are indicated for a HTO by a orthopaedic surgeon and meet the inclusion
criteria can be included. Patients will be randomised between HTO en KJD (2:1).
structural and clinical outcome parameters are evaluated over time up to 2
years.
Data on direct and indirect costs as well as change in quality of life are
gathered by use of questionnaires.
Intervention
KJD is performed according to the methodology as used in previous knee
distraction studies, using 2 monotubes, one laterally and one medially.
Intra-operative the tubes are distracted 2 mm. During hospitalization the frame
is further distracted, 1mm a day, until in total 5 mm is reached. Distraction
lasts for 6 weeks whereby fully load bearing is encouraged, with crutches for
stability. After 6 weeks the frame is removed at day-care surgery. HTO is
performed as usual according to the clinical protocol.
Study burden and risks
All patients included will visit the outpatient clinic more frequently, namely
a total of ten times in two years. At this visit questionnaires have to be
filled in. Additionally 10 ml of blood and 5 ml of urine will be collected, an
X-ray will be taken and 3 times a MRI examination will be performed, at
baseline (KJD+HTO), 1yr (KJD) and 2yr (KJD+HTO) evaluation. Patients treated
with KJD have the chance of developing pin-tract infections; this is a known
complication of a *fixateur externe*. These skin infections can be effectively
treated with antibiotics. Another possible disadvantage of KJD is that there is
a higher risk for knee joint contracture, aimed to prevent by adequate
physiotherapy. Rehabilitation will not be significantly different from HTO.
Heidelberglaan 100
3508 GA Utrecht
Nederland
Heidelberglaan 100
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Patients with medial or lateral tibio-femoral compartmental OA considered for HTO according to regular clinical practice
Age < 65 years
Radiological joint damage: Kellgren & Lawrence score >2
Intact knee ligaments
Normal range-of-motion, normal stability
Maximum flexion limitation of 15 degrees (minimum of 120 degrees flexion pre-operative)
Body Mass Index < 35
Exclusion criteria
Mechanic axis-deviation of more than 10 degrees
Psychological inabilities or difficult to instruct
Not able to undergo MRI examination according to standard checklists
Inflammatory or rheumatoid arthritis present or in history
Post traumatic fibrosis due to fracture of the tibial plateau
Bone-to-bone contact in the joint (absence of any joint space on X-ray)
Surgical treatment of the involved knee < 6 months ago
Contra-lateral knee OA that needs treatment
Primary patello-femoral osteoarthritis
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 | NL34302.041.10 |