The main objective is to compare range of motion between a mobile bearing posterior stabilized knee device and its non-stabilized mobile bearing counterpart. Secondary objective is to compare patient reported outcome measures (PROMs) between both…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is range of motion, measured on a short-leg
radiograph, of the operated knee 1 year postoperative.
Secondary outcome
Other measurements of range of motion (goniometer) and patient reported outcome
measures (KOOS; NRS pain and satisfaction; EQ5D; FJS-12)
Background summary
Total Knee Arthroplasty (TKA) is a successful procedure and remains the golden
standard for treatment of invalidating symptoms of osteoarthritis. Maximal knee
flexion and range of motion is one of the parameters that is proven to be
highly correlated to patient satisfaction after TKA. It is theorized a mobile
bearing posterior stabilized artificial knee offers deeper flexion than its
mobile bearing (non-stabilized) counterpart due to the more constrained nature.
Study objective
The main objective is to compare range of motion between a mobile bearing
posterior stabilized knee device and its non-stabilized mobile bearing
counterpart. Secondary objective is to compare patient reported outcome
measures (PROMs) between both knee systems 1 year postoperative.
Study design
Patient blinded, randomized controlled trial.
Intervention
The study group will receive the Advanced Coated System (ACS) mobile bearing
posterior stabilized knee system and the control group will receive the ACS
mobile bearing (non-stabilized) knee system.
Study burden and risks
All patients will be seen at regular follow-up intervals identical to standard
knee arthroplasty protocol at our clinic, with 1 additional visit for the
current study. Patients will additionally be asked to undergo measurements of
range of motion on the operated side, for which an additional short-leg
radiograph is required.
Laarderhoogtweg 12
Amsterdam 1101AE
NL
Laarderhoogtweg 12
Amsterdam 1101AE
NL
Listed location countries
Age
Inclusion criteria
- Age between 18-80 years
- BMI<35
- End stage knee osteoarthritis warranting total joint arthroplasty
- In stable health, suitable for surgery, willing and able to participate in
the follow-up program.
- Understanding of Dutch/English language.
- Written and signed Informed Consent
Exclusion criteria
- Revision of unicondylar or previous total knee arthroplasty
- Skeletal immaturity
- Charcot joints
- Patellar resurfacing and/or placement of a patellar prosthesis
- Previous high tibial osteotomy
- Rheumatoid arthritis
- Inability to complete the exercises due to contralateral knee
osteoarthritis/arthroplasty or hip osteoarthritis/arthroplasty
- Previous arthrofibrosis or pre-operative flexion <90 degrees
- Unable (due to mental and/or cognitive comorbidities) or unwilling to
cooperate in the follow¬-up program
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 | NL72684.018.20 |