Goals is Doel to study whether this new distractor is indeed more userfriendly.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
duration needed to place the distraction frame
Secondary outcome
questionnaire regarding user friendliness for the patient
Background summary
Total knee prostheses are placed in case no treatment options are available
anymore 10.000/year in patients below the age of 65 years
Knee distraction is a joint saving treatment for these relatively young
patients and can postpone a first total knee prosthesis and with that can
prevent the change for revision surgery later in life.
The presently available knee distractor is a proof-of-concept device and not
suitable for broad implementation in clinical practice.
The UMC Utrecht has developed a user friendly knee distractor together with
ArthroSave BV (ArthroSave's KneeReviver) specifically designed for knee
distraction as treatment for osteoarthritis, enabling broad implementation in
clinical practice.
Study objective
Goals is Doel to study whether this new distractor is indeed more userfriendly.
Study design
randomized 3-center study comparing user-friendliness of the proof-of-concept
distractor with ArthroSave's KneeReviver
Intervention
knee distraction with ArthroSave's KneeReviver
Study burden and risks
Burden is not different (potentially less) than regular distraction treatment.
Only 2 short questionnaires are filled in. ArthroSave*s Knee-Reviver has never
been tested on humans in clinical practice. This provides a potential risk of
unforeseen complications. The change is very small. In that case a
conventional distractor can be placed. With this proven effective distractor
treatment can be continued.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- adults *65 years of age (at higher ages cost-benefit is becoming less; 15)
- BMI < 35 kg/m2 (mechanical safety limit of device) (with 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; 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 | NL60309.041.17 |