Feasibility of knee motion reproduction method for application in a hinged knee distraction device to apply reliable comfortable hinged knee joint distraction to be tested in future clinical studies.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Joint space width on standardised X-rays evaluated by knee image digital
analyses (KIDA; Marijnissen A, et al, O&C 2008).
Reliable hinged knee joint distraction: viz. enlarged (>3 mm as compared to no
distraction) joint space width under X-ray vision under extension and flexion
(0-30 degrees) during weight bearing; with smooth joint movement (0-30 degrees
flexion; arbitrary to the patients satisfaction, and orthopaedic surgery*s
judgement) during flexion/ extension.
Secondary outcome
Optimal process characteristics including motion capture, manufacturing of
patient specific part, and distraction application. These parameters are
arbitrary and relate to feasibility, logistics, time, etc. Only based on the
first experience in the proposed feasibility study exact endpoints can be set
with input of all stakeholders for future treatment studies.
Background summary
Knee joint distraction with a conventional (viz. stiff) joint distraction
device in treatment of severe knee osteoarthritis (OA) has shown significant
prolonged clinical benefit compared to pre-treatment conditions (decreased pain
and increased function). At present knee joint distraction becomes implemented
in clinical practice.
During conventional distraction, flexion (motion) of the knee joints is not
possible for 6-8 weeks. This is despite good and prolonged clinical benefit, a
significant discomfort for patients during the distraction period.
We developed, mechanically tested, and patented a (personalised) hinged knee
joint distractor. This new hinged distractor uses exactly the same bilateral
fixation technique as the conventional stiff distractor. However, hinges are
used to bridge the joint which have a patient-specific part inside that
accurately reproduces the patient-specific joint motion. To capture the
patient*s specific movement, a non-invasive digital measurement tool has been
developed as accessory to the hinged distractor. Dedicated software generates
data for automated manufacturing of the patient-specific parts of the hinged
knee distractor. These are manufactured directly and are placed in the hinged
distraction device.
Feasibility and proof of correct of the process of motion reproduction and
manufacturing of the patient specific parts as well as the actual hinged
distraction is required before the technique of hinged knee distraction can
actually be applied in an experimental treatment (feasibility/safety) study.
Study objective
Feasibility of knee motion reproduction method for application in a hinged knee
distraction device to apply reliable comfortable hinged knee joint distraction
to be tested in future clinical studies.
Study design
Observational, technical feasibility study, with invasive (X-ray) measurements
without follow-up.
Study burden and risks
Patients will visit during conventional (stiff) distraction the outpatient
clinic on a regular basis. At one of these visits a day-care visit for the
present study is scheduled. The hinged distractor is fixed to the same bone
pins in place for conventional distraction. There is no direct benefit for the
patients in this study. The burden is significant during this specific one day
study visit. The risks are limited. In the first knee joint distraction studies
(METC 01-146 and 04-086) conventional distraction tubes were every two weeks
removed during day-care and patients knee flexion was exercised for several
hours on a continuous passive motion device. This was done over a 2-3 months
period (3-5 times). Every time distraction was regained and checked by X-ray.
Based on this experience the risk of removing and reinstalling conventional
distraction is considered limited. The extra 7 radiographs is an acceptable
risk and not uncommon in regular practice for diagnosis and follow-up of knee
osteoarthritis.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
25BMI < 35
Normal-good physical condition (arbitrarily defined by orthopedic surgeons)
Normal knee joint stability
Normal range of motion (including full extension)
Radiographic signs of joint damage (KL grade 2-3)
Exclusion criteria
- Comorbidities that could interfere with the study (arbitrary defined by orthopaedic surgeons)
- History of inflammatory or septic arthritis
- Knee mal-alignment of more than 5 degrees
- Previous severe ligament damage (including reconstructions)
- Previous intra-articular fractures
- Laser treatment of cartilage
- Previous surgical interventions of the distracted knee < 6 months ago
- Absence of any joint space width on either site (medial or lateral) of X-ray
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 | NL48424.041.14 |