The present study aims at a small randomised study demonstrating user friendliness of the 'user friendly' knee joint distractor compared to the experimental 'proof of concept' device (2*15 patiënten). Additionally the study aims…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A: surgery time needed to place the knee joint distractor
B: clinical efficacy by KOOS/WOMAC questionaire based on pain, function and
stifness after 2 years
Secondary outcome
A: convienence/burden of wearing the device for 6-7 weeks of the knee
distractor (questionnaire)
B: joint space width (cartilage thickness) on radiographs after 2 years
Background summary
Severe knee osteoarthritis below the age of 65 years can effectively be treated
with 'knee joint distraction' being a joint saving surgery.
The UMC Utrecht has gathered ample evidence that knee joint distraction using a
'proof-of-concept' (experimental) knee joint distractor is very
(cost)effective. Recently the UMC Utrecht has developed a CE certified 'user
friendly' knee distractor with similar mechanical properties and making use of
the same bone pin locations, but more easy (quicker) to install for the
orthopaedic surgeon and more easy (less burdensome) to wear for the patient.
Study objective
The present study aims at a small randomised study demonstrating user
friendliness of the 'user friendly' knee joint distractor compared to the
experimental 'proof of concept' device (2*15 patiënten). Additionally the study
aims in a large patient group (n=+60) to confirm clinical efficacy of the novel
'user friendly' knee joint distractor by demonstrating non-inferiority compared
to retrospective data obtained from clinical studies with the
'proof-of-concept' device.
Study design
A: user friendliness: multi centre open randomised study
B: efficacy: multi centre open observational study with retrospective
comparison
Intervention
'user friendly' knee joint distraction (vs. 'proof-of-concept' knee
distraction)
Study burden and risks
- limited unexpected risk of failure of the new 'user friendly'knee joint
distractor
- limited extra time needed to fill in questionnaires
- minimal risk because of increased radiation exposure due to two extra knee
x-rays
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with severe knee osteoarthritis (persisting conventional treatment resistant pain and cartilage tissue damage) considered for total (or uni) knee arthroplasty or high tibial osteotomy (with limited axis deviation), in general practice by the orthopaedic surgeon offered knee joint distraction as alternative treatment.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- adults *65 years of age (at higher ages cost-benefit is becoming less; 15)
- BMI < 35 kg/m2 (mechanical safety limit of device) (max 110 kg body weight)
- Normal-good physical condition (arbitrary defined by orthopaedic surgeons)
- Sufficient knee joint stability (arbitrary defined by orthopaedic surgeons)
- Sufficient range of motion (arbitrary defined by orthopaedic surgeons)
- Radiographic signs of joint damage (KL grade 2-4)
- VAS (visual analogue scale) pain >40/100 (conservative treatment resistant)
Exclusion criteria
General: Patients that would not be considered for arthroplasty or osteotomy because of psychosocial condition (e.g. pain syndroms); or who meet any of the following criteria will be excluded from participation in this study:
- Comorbidities that would compromise the efficacy of knee joint distraction (arbitrary defined by orthopaedic surgeons)
- History of inflammatory or septic arthritis
- Knee mal-alignment of more than 10 degrees
- Previous surgical interventions of the index knee < 6 months ago
- Absence of any joint space width on both sides (medial and lateral) of X-ray
- presence of an endo-prostheses elsewhere
Design
Recruitment
Medical products/devices used
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 | NL57631.041.16 |