The primary objective of the study is to investigate whether the postoperative tibiofemoral contact point in 90 degrees of flexion will be at the designed position for this specific implant (PCL-retaining Genesis II TKR). The secondary objective of…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The postoperative medial tibiofemoral contact point of the knee in 90 degrees
of flexion.
Secondary outcome
Antero-posterior stability of the knee, clinical and functional outcomes (Knee
Society Score (KSS), KOOS, patellofemoral score), active and passive ROM, VAS
pain and satisfaction.
Background summary
Measuring the step off during surgery (spacer technique) is a newly developed
operative strategy to determine the ideal contact point of the femur with the
tibia postoperative and to balance the posterior cruciate ligament (PCL).
Engineers have calculated the ideal step off for every size of the total knee
replacement (TKR), with which the tibiofemoral contact point in 90* will be at
the designed position. For this specific implant (PCL-retaining Genesis II TKR)
this will be at 66% (+/- 5%) of the anterior/posterior distance.
If the PCL is balanced well, the postoperative anteroposterior stress X-ray
will show that there will be less than 4 mm posterior translation of the medial
contact point compared with the *not stressed* X-ray.
Study objective
The primary objective of the study is to investigate whether the postoperative
tibiofemoral contact point in 90 degrees of flexion will be at the designed
position for this specific implant (PCL-retaining Genesis II TKR).
The secondary objective of this study is to measure the anteroposterior laxity
in 90 degrees of flexion.
Study design
The study has designed as a mono-centre cohort study. A total of 42 consecutive
patients will receive the PCL-retaining Genesis II total knee replacement. Two
surgeons will perform the spacer technique during the surgeries.
In all patients the contact point will be determined on X-rays with 3D
software. Additionally, AP-stress X-rays will be performed to test the PCL
function. AP laxity will also be measured and several clinical and functional
socres (KSS, patella score, LEFS, KOOS, and VAS pain and satisfaction) will be
administered.
Study burden and risks
There is no additional risk with regard to the investigated "spacer technique".
This technique will only confirm and quantify the ususal protocol for total
knee replacement during the surgery. In order to determine the exact
postoperative effect on stability and contact point extra radiographs are
necessary. These extra radiographs have a lower radiation dose than regular
X-rays, however, they cannot replace the regular X-rays. The total amount of
radiation is only slightly higher than during regular follow-up. Patients will
visit the clinic at 2 years follow-up. This follow-up moment is extra for the
study and therefore travel reimbursement will be available for all patients.
Hengstdal 3
6574 NA Ubbergen (bij Nijmegen)
NL
Hengstdal 3
6574 NA Ubbergen (bij Nijmegen)
NL
Listed location countries
Age
Inclusion criteria
- Patient presenting with non-inflammatory osteoarthritis (radiologically confirmed), requiring total knee replacement
- Patient has an intact PCL and patient has indication for a PCL-retaining Genesis II TKR
- Patient is 40 to 70 years of age, inclusive
- Patient plans to be available for follow up through 2 years postoperative.
- Patient is in a stable health and is free of, or treated for, cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk.
Exclusion criteria
- Patient is known to have insufficient femoral or tibial bone stock
- Patient has shown to have insufficient posterior cruciate ligament during surgery
- 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 or knee replacement surgery in the last 6 months, or is planned to have a (second) hip or knee replacement in the next 6-12 months
- Patient has had major, non-arthroscopic surgery to the study knee, including HTO.
- Patient has an active, local infection or systemic infection
- Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow up
- Patient has grade 3 collateral ligament insufficiency
- 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 has varus or valgus deformity >10 degrees
- Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder
- Patient is pregnant or plans to become pregnant during course of study
- Patient has a known sensitivity to materials in the device
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 | NL36576.072.11 |