1. Is there a difference in clinical and/or functional outcome between patients older than 60 years undergoing unicompartmental or total knee arthroplasty.2. Is there a relationship between the degree and location of preoperative arthroscopic…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
WOMAC-score
Secondary outcome
1.KSS, UCLA activity 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 predominantly medial knee osteoarthritis 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.
The absence of osteoarthritis in the lateral knee compartment as seen on X-rays
is an important factor for succesful unicompartmental knee arthroplasty. Not
all osteoarthritis can be seen on X-rays, so it could be that unicompartmental
knee arthroplasty is performed in "unsuitable" patients.
Study objective
1. Is there a difference in clinical and/or functional outcome between patients
older than 60 years undergoing unicompartmental or total knee arthroplasty.
2. Is there a relationship between the degree and location of preoperative
arthroscopic chondropathy and the functional outcome after unicompartmental
knee arthroplasty.
Study design
This is a double blind, multicenter, randomized controlled trial (RCT)
Intervention
Patients will be classified/randomized into one of two groups: combined
arthroscopy with unicompartmental knee arthroplasty OR combined arthroscopy
with total knee arthroplasty. 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 2,5 hours. Pre- and postoperative laboratory
samples and extra X-rays are taken. Complications associated with knee
arthroplasty are thrombosis, infection, excessive blood loss and delayed wound
healing. The arthroscopy in combination with knee arthroplasty does not cause
(in our opinion) additional complications during or after surgery. However, it
does lead to an extended surgery-time (10 minutes extra).
Groot Wezenland 20
8011 JW Zwolle
Nederland
Groot Wezenland 20
8011 JW Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
Osteoarthritis in the medial compartment of the knee.
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 | NL15781.075.07 |