The minimal duration of an effective distraction period has not yet been determined. In the past, two months distraction showed comparable results with three month distraction. In this study, we would like to analyse the effectivity of a one month…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter will be clinical effectivity determined by the
WOMAC questionair on pain, function and stiffness. Structural effectivity will
be analysed on x-ray and MR. The treatment with one month distraction is
considered effective if three out of four patients have comparable results with
the previous study of two months distraction.
Secondary outcome
A secundary outcome parameter is clinical effectivity based on physical
examination. There will also be a more specific analysis on biological change
of the joint by biomarker and MR analysis.
Pin tract infections will be registered and retrospectively compared to the two
month distraction study.
Background summary
Knee osteoarthritis is a degenerative joint disorder affecting a large part of
our population (10%). Current treatment aims at diminishing symptoms instead of
curing the disease.
Joint distraction in ankle osteoarthritis has proven its effectivity; twothirds
of patients have good results for at least ten years. Actual joint
regeneration, 'cure', is suggested on x-ray. Preliminary results in studying
knee distraction are also very promising, pain decreases and again joint
regeneration is suggested on MR and x-ray.
The current method for the knee joint consists of two months distraction with a
external fixator, which is a very invasive treatment, especially for the
patient but also for our health system. Pin tract infection is a very common
and painfull complication. Also, the two month fixation of the knee joint
effects muscle condition and knee flexion range, resulting in a long
revalidation period.
Study objective
The minimal duration of an effective distraction period has not yet been
determined. In the past, two months distraction showed comparable results with
three month distraction. In this study, we would like to analyse the
effectivity of a one month distraction period on severe knee osteoarthritis.
Considering the burden of the distraction period for patient as well as for the
health system, a reduction of this period would make this promising treament
more suitable for broader implementation.
Study design
In this pilot study four patients will be treated with one month joint
distraction. These patients will be followed for one year.
Intervention
Patients will be treated with an external fixator bridging the knee joint. Two
monotubes are placed on bone pines, four pins in the femur and four in the
tibia. The joint is distracted for at least five millimeter during the first
few days. Every week, patients come back to the outpatient clinic to see if
distraction is still present and check for pin tract infections. After one
month the distraction frame is removed under general anesthesia and the knee
joint is flexed. The patient will be followed for one year.
Study burden and risks
Joint distraction is an invasive treatment with a significant risk on
complications. The main complication is pin tract infection, as occurs with all
external fixators, which can be treated effectively with antibiotics and pain
medication.
This specific group of young knee osteoarthritis patients has no other
treatment options. Thusfar, results of joint distraction are very promising.
Our purpose in this study is to combine the promising effectiveness of this
treatment with a more acceptable treatment method for the patient.
Heidelberglaan 100
3584 GA Utrecht
Nederland
Heidelberglaan 100
3584 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Age < 60 yrs
Primarily tibia-femoral osteoarthritis
Clinical indication for arthroplasty or osteotomy
Radiographic knee OA; K&L > 2
Exclusion criteria
Bilateral knee osteoarthritis
Joint malalignment > 10°
History of infectious arthritis
Primarily patello-femoral osteoarthitis
Knee instability with physical examination
Psychological difficulties which interfer with joint distraction
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 | NL25701.041.09 |