Is there a difference in clinical and/or functional outcome between patients older than 60 years undergoing unicompartmental or total knee arthroplasty.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
WOMAC-score
Secondary outcome
1.KSS and SF-36-score
2.Complications, revisions
3.Postoperative flexion of the operated knee
4.Radiographical analysis
5.Hospital- and recoveryperiod
6.Bloodloss (Hb pre- en postoperative, peroperative bloodloss, transfusions)
Background summary
Patients with osteoarthritis in the medial compartment of the knee can be
treated with unicompartmental or total knee arthroplasty. Which one of the two
should have preference in patients suitable for unicompartmental knee
arthroplasty is unclear.
Study objective
Is there a difference in clinical and/or functional outcome between patients
older than 60 years undergoing unicompartmental or total knee arthroplasty.
Study design
This is a double blind, multicenter, randomized controlled trial (RCT)
Intervention
Blinding is done by utilising a straight paramedian medial incision through
which both UKA and TKA can be adequatly performed. The initial incision length
is 25 cm for TKA and 10 cm for UKA. The 10 cm incision in UKA is superficially
extended (on the skin, both proximal and distal), when closing the wound, to
the total length of 25 cm necessary for blinding.
Study burden and risks
The total time-burden is about 1 hour (extra when compared to the normal
procedure regarding knee arthroplasty). Pre- and postoperative laboratory
samples and X-rays are taken. Complications associated with knee arthroplasty
are thrombosis, infection, excessive blood loss and delayed wound healing.
Groot Wezenland 20
8000 GM Zwolle
Nederland
Groot Wezenland 20
8000 GM Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
Patients with isolated medial compartment osteoarthritis. Patients must have an healthy intact lateral knee compartment, which is determined on X-rays (stage 0 Kellgren and Lawrence- and Ahlback-classification on standard standing AP, lateral and valgusstress knee X-ray).
Exclusion criteria
1. Inflammatory arthropathy (RA, SLE, arthritis psoriatica)
2. Recent septic arthritis
3. Flexion contracture > 10 degrees
4. Preoperative range of motion (ROM) < 90 degrees
5. Angular deformity, fixed or > 15 degrees
6. Deficient anterior cruciate ligament
7. Previous high tibial osteotomy (HTO)
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 | NL20729.075.07 |