1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?2. Is KJD superior to HTO in actual structural repair of cartilage?3. Is KJD cost-effective in the long-term compared to HTO and TKP?
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. Clinical effectiveness determined by WOMAC.
Secondary outcome
2. Structural repair of cartilage as detemined on X-rays and MRI (only in
patients treated with KJD and HTO).
3. Costs -effectiveness measured using long-term (life-long) medical and
non-medical costs and Quality Adjusted Life Years as calculated, using the
health economic model
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) and total knee prosthesis (TKP) in two separate
substudies. It is expected that KJD has equivalently or better clinical
outcome.
Study objective
1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?
2. Is KJD superior to HTO in actual structural repair of cartilage?
3. Is KJD cost-effective in the long-term compared to HTO and TKP?
Study design
This study will be accomplished at the St. Maartenskliniek in Woerden (SMKW).
Ad 1) Two individual substudies (i.e. radomized controlled trials) are
performed. One within patients considered for either HTO (cohort A) and one
within patients considered for TKP (cohort B). Inclusion criteria are used so
that all patients are also indicated to undergo KJD. In both cohorts patients
are randomised to conventional treatment or KJD. Clinical outcome parameters
are scored over 2 years and compared between treatment strategies within the
two cohorts.
Ad 2) In cohort A (and patients undergoing KJD within cohort B) patients are
also are evaluated for cartilage repair activity.
Ad 3) To calculate the model parameters as needed for the economic evaluation,
a previously used and validated health-economic model for direct and indirect
costs is used. This model is related to treatment and quality of life outcomes
which will be measured in all cohorts. Furthermore, a third cohort of patients,
undergoing knee-revision surgery (KReS, cohort C), is followed using the same
measurements.
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, TKP and KReS are performed as usual according to the clinical protocol.
Study burden and risks
All patients included in cohort A or B will visit the outpatient clinic more
frequently, namely seven times in two years. At this visit questionnaires have
to be filled in, 10 ml of blood and 5 ml of urine will be collected and an
X-ray will be taken.
For patients treated with KJD or HTO additionally 3 times a MRI examination
will be performed, at baseline, 1yr and 2yr 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 or TKP.
Heidelberglaan 100
3508 GA Utrecht
Nederland
Heidelberglaan 100
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Cohort A:
* Patients considered for HTO according to regular clinical practice
* Age < 65 years
* Radiological joint damage: Kellgren & Lawrence score > 2 (*2: mild but definite osteophyte formation, with essentially normal joint space width*)
* Normal range-of-motion, normal stability
* Maximum flexion limitation of 15 degrees (minimum of 120 degrees flexion pre-operative)
* Mechanic axis-deviation 5-10 degrees
* Non smoking
* Body Mass Index < 35;Cohort B:
* Patients considered for TKP according to regular clinical practice
* Age < 65 years
* Radiological joint damage: Kellgren & Lawrence score *2 (*2: mild but definite osteophyte formation, with essentially normal joint space width*)
* Intact knee ligaments
* Normal range-of-motion, normal stability
* Maximum flexion limitation of 15 degrees (minimum of 120 degrees flexion pre-operative)
* Non smoking
* Body Mass Index < 35;Cohort C:
* Patients considered for KReS according to regular clinical practice
* First revision of a TKP
* The original TKP placement under the inclusion criteria as defined for cohort B
Exclusion criteria
For cohorts A and B:
* Psychological inabilities or difficult to instruct
* Claustrofoby and therefore fear of MRI examination
* Inflammatory or rheumatoid arthritis present or in history
* Bone-to-bone contact in the joint (absence of a joint space on X-ray)
* Surgical treatment of the involved knee < 6 months ago
* Primary patello-femoral osteoarthritis;For cohorts C:
* Placement of the original TKP under the exclusion criteria as defined for cohort B.
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 | NL31659.041.10 |