The primary objective is to compare the Vanguard XP with a CR TKA in terms of kinematics during functional tests using 3D fluoroscopy. The secondary objective is to compare both TKAs in terms of 3D migration of the prosthesis up until 2 years post-…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The posterior femoral rollback (i.e. translation) in mm from 30° flexion to 0°
extension during the step-up test.The endpoint of this parameter is set at one
year post-operative. This will be measured using MCM-based RFA (p18 in the
protocol).
Secondary outcome
•the total anterior femoral rollback in mm from 0° extension to 90° flexion
during the lunge test. This will also be done by using MCM-based RFA
•3D migration (i.e. translation and rotation) in mm of the tibial and femoral
component of the implant up and until 2 years (7.5 years for follow-up), using
model-based radiostereometric analysis (MB-RSA, p19 protocol)
•Lateral femoral lift-off in mm at 90° knee flexion during lunge test using
MCM-based RFA.
•AP laxity of knee in mm from anterior to posterior using a rolimeter
•Functional power output of the leg using the Leg extension power rig
•Patient and Clinician Reported Outcome Measures (PROMS and CROMS)
•Operative information
Background summary
Total knee arthroplasty (TKA) is one of the most successful orthopedic
operations, especially in terms of pain reduction and survival. Currently, two
types of TKA design are the most common: the cruciate retaining (CR) TKA and
the posterior stabilized (PS) TKA. The literature has shown mixed results
concerning recovery of knee kinematics after placement of CR and PS TKAs. In
contrast to TKA designs where one or both cruciate ligaments is removed, a
bi-cruciate retaining (BCR) TKA can be hypothesized to lead to better
functional outcome. A recent developed BCR TKA is the Vanguard XP (Biomet,
Inc., USA). However, to date functional outcome of the Vanguard XP has not been
properly studied to warrant this as a standard procedure.
Study objective
The primary objective is to compare the Vanguard XP with a CR TKA in terms of
kinematics during functional tests using 3D fluoroscopy. The secondary
objective is to compare both TKAs in terms of 3D migration of the prosthesis up
until 2 years post-operative. With the follow-up study we want to investigate
whether the micromotion between the BCR TKA and the bone stabilizes over time,
from 2 until 7.5 years post-operative.
Study design
A single blind randomized trial with two groups (BCR vs CR).
Intervention
CR or BCR TKA (Vanguard System, Biomet, Inc., USA).
Study burden and risks
The extra amount of time over the two years that a patient invests in the study
is about 11 hours (+2.5 hours for the follow-up participants). There is no
additional risk other than the regular risks for a surgery of a primary TKA.
The questionnaires and physical examinations of the knee do not bring any extra
burden and the additional radiological assessments have a total amount of
radiation that leads to a very small extra risk.
Hengstdal 3
Ubbergen 6574 na
NL
Hengstdal 3
Ubbergen 6574 na
NL
Listed location countries
Age
Inclusion criteria
•Patient with non-inflammatory knee osteoarthritis, which is confirmed by
radiology.
•Osteoarthritis is unilateral of bilateral with the contralateral knee
functioning properly, not operated on in the last 6 months and not planned for
TKA in the coming 2 years.
•Patient is set to receive a primary cemented total knee arthroplasty.
•Age between 40 and 75 years, inclusive.
•Patient plans to be available for follow-up until two years post-operative.
•Patient is in stable health (ASA-score <= 3) and is free of or treated for
cardiac, pulmonary, haematological, or other conditions that would pose
excessive operative risk.
•Patient has a correctable or <10º rigid (non-correctable) varus or valgus
deformity of the knee.
•Participants must be able to give informed consent and be cognitively intact.
Exclusion criteria
•Patient has a BMI > 35.
•Patient's expected physical activity after surgery is 2 or less on the UCLA
Activity Scale.
•Patient has had previous hip replacement surgery in the last 6 months, or is
planned to have a hip replacement in the next 6-12 months (because of the
effect on function).
•Patient has had major, non-arthroscopic surgery to the study knee, including
HTO.
•Patient has an active, local infection or systemic infection
•Prior high-energy trauma to the affected knee or prior history of anterior
and/or posterior cruciate ligament rupture.
•Suspicion of anterior and/or posterior cruciate ligament rupture at clinical
examination.
•Documented osteoporosis with patient in active medical treatment.
•Patient has an active, local infection or systemic infection.
•Patient has physical, emotional or neurological conditions that would
compromise compliance with post-operative rehabilitation and follow-up.
•Bone quality compromised by disease, infection or prior implantation which
cannot provide adequate support and/or fixation to the prosthesis
•Severe instability of the knee joint secondary to the absence of collateral
ligament integrity and function
•Patient has knee flexion < 90 degrees
•Patient has fixed flexion deformity >10 degrees (passive extension lag)
•Patient has > 30 degrees extension deficit (active restraint to extension)
•Patient does not have a proper functioning patella tendon on the affected
side; measured as inability of active extension of the knee
•Patient has quadriceps weakness on the affected side; score on MRC scale < 4
•Patient has rheumatoid arthritis, any auto-immune disorder, immunosuppressive
disorder or a terminal illness.Intraoperative Exclusion
•If the anterior and/or posterior cruciate ligament are found missing or
totally ruptured at direct intraoperative visualization. Patients excluded at
this point will receive a CR prosthesis when PCL is retained or an anterior
stabilized bearing prosthesis when the PCL is absent.(c) =
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 | NL54336.048.15 |