PrimaryTo evaluate the alignment of the Signature* CT-based procedure compared to the Signature* MRI-based instruments.SecondaryTo evaluate the efficacy of the CT-based Signature* procedure in terms of operation time compared to the Signature* MRI-…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outliers in alignment of the femoral and tibial prosthesis in the frontal
plane, measured on radographs made 6 weeks after operation and compared between
the CT-based Signature* procedure and the standard MRI-based Signature*
Occurrence (and percentage) of outliers in alignment in the frontal, sagittal
and horizontal plane of femoral and tibial components.
Occurrence (and percentage) of outliers in alignment of the mechanical axis of
the leg.
Difference in thickness of the in vivo inserted polyethylene compared to
pre-operatively calculated thickness of this
insert.
Accuracy of the guides
Secondary outcome
Operation time
Fit, form and practical use of the Signature* alignment guides.
Needed change of plans per-operative: change of size of prosthesis, conversion
Signature procedure to conventional
procedure for any reason
Background summary
Signature* for total knee arthroplasty (TKA) is a patient specific alignment
guide based on MRI-images or a CT-scan.
This type of guiding makes conventional guiding unnecessary.
The principle aims of this study are: to investigate whether the CT-based
Signature* for TKA, is at least as effective
in radiological outcome as the Signature* based on MRI and to investigate
whether Signature* CT-based results in a
larger percentage of prosthesis placed correctly (within guidelines of 3
degrees varus and 3 degrees valgus).
Furthermore, a third aim of
Furthermore, a third aim of the study is to compare the preoperatively planned
alignment of the prothesis with the
actual alignment in vivo.
Study objective
Primary
To evaluate the alignment of the Signature* CT-based procedure compared to the
Signature* MRI-based instruments.
Secondary
To evaluate the efficacy of the CT-based Signature* procedure in terms of
operation time compared to the Signature* MRI-based instruments
To evaluate the safety of the CT-based Signature* procedure in terms of
needed change of plans compared to the Signature* MRI-based instruments
Verify the fit, form and practical use of the CT-based Signature* compared to
the Signature* MRI-based instruments:
To determine the occurrence (and percentage) of outliers in alignment in the
frontal, sagittal and horizontal plane of femoral and tibial components.
Outliers are defined as deviations > 3 degrees from preoperative planning.
To determine the occurrence (and percentage) of outliers in alignment of the
mechanical axis of the
leg. Outliers are defined as deviations > 3 degrees from preoperative planning.
Verify to what extend the thickness of the in vivo inserted polyethylene
corresponds with the preoperatively
calculated thickness of this insert.
Study design
A Prospective, Randomized study
Patients will be randomized to be operated on with the use of the MRI -based
Signature*(control group), or
CT-based Signature* (trial group). Patients have an equal opportunity of being
assigned to the trial group or control group. The
randomization will occur via a random number generator. The surgeon or clinical
researcher does not choose the
participants for each group. The patients are informed on the type of
prosthesis placement that has been carried
out.
Intervention
NA
Study burden and risks
The CT scan uses radiation. This radiation can be detrimental when administered
in high doses. However, it is expected that the radiation dose that will be
used, will not have significant negative side effects on the health of the
patients.
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
-Patients scheduled to undergo primary TKA replacement with any of the following indications
*Painful and disabled knee joint resulting from osteoarthritis.
*High need to obtain pain relief and improve function,
-Body-mass-index (BMI) <35
-Ablility and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
-Consent form read, understood and signed by patient.
Exclusion criteria
-Active infection in knee
-General infection
-Distant foci of infections which may spread to the implant site
-Failure of previous knee joint replacement
-Pregnancy
-Previous major knee surgery, except for arthroscopic meniscectomy.
-Metal near knee joint (MRI-scan not possible)
-Not able or willing to undergo MRI-scan or CT-scan
-Reumatoid arthritis
-Non-correctable varus axis
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 | NL46625.096.13 |