Clinical, prospective, non-randomized trial Orbis Medsich Centre, Sittard-Geleen
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the preoperatively planned, computer-based Signature* alignment plan
with the actual achieved alignment in the frontal, coronal and sagittal plane
in vivo postoperatively of both the femur and tibia components of the total
knee arthroplasty.
Secondary outcome
To determine the occurrence (and percentage) of outliers in alignment in the
frontal, sagittal and horizontal plane of femoral and tibial components.
To determine the occurrence (and percentage) of outliers in alignment of the
mechanical axis of the leg.
Verify the fit, form and practical use of the Signature* alignment guides.
Verify to what extend the thickness of the in vivo inserted polyethylene
corresponds with the pre-operatively calculated thickness of this insert.
Background summary
So far, there were basically two types of operation methods on total knee
arthroplasty, namely one that uses intramedullary alignment, the conventional
method, and the perioperative computernavigaded placement of a TKA. At Orbis
Medical Center, we have experience with the Signature system developed by
Biomet.
Signature uses patient-specific templates for femoral and tibial component of
the TKP-standard system locations. The production of the molds starts 5 weeks
before surgery with an MRI scan of the hip, knee and ankle of the leg of the
patient. Software is used to calculate the most suitable size and position of a
set of existing prosthetic components, such that a neutral mechanical leg axis
postoperatively is created. The software uses bony reference points.
The overview of the proposed placement is summarized in a digital map. This
plan is sent to the orthopedic surgeon who will perform the surgery. If
necessary, adjustments for placement of the prosthesis can be made.
The patient-specific templates fit only one way to the femur (Figure 2) and
tibia (Figure 3). Using these molds, pins are drilled in the femur and tibia to
determine the position of the cutting blocks.
Study objective
Clinical, prospective, non-randomized trial
Orbis Medsich Centre, Sittard-Geleen
Study design
Comparison of the preoperatively planned adjustment of the prosthesis, as
determined by the software and based on the MRI scan with the actual
postoperative alignment of the prosthesis on Signature * Personalized Patient
Care in the frontal, transverse and sagittal plane.
Study burden and risks
The main potential risks of a knee prosthesis infection, loosening, fracture,
thrombosis or continuous pain. Moreover, the Signature * guides allergic
reactions to materials used in the guides. However, the guides are only for
adjusting the prosthesis and will be removed after the surgery.
The usual risks of performing a CT scan apply.
Dr. H. van der Hoffplein 1
6162 BG Sittard-Geleen
NL
Dr. H. van der Hoffplein 1
6162 BG Sittard-Geleen
NL
Listed location countries
Age
Inclusion criteria
Patients scheduled to undergo primary total knee replacement with any of the following indications
Painful and disabled knee joint resulting from osteoarthritis.
One or more compartments are involved, as assessed by X-ray.
High need to obtain pain relief and improve function,
Above 18 years old (full skeletal maturity)
Body-mass-index (BMI) <38
Ability 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 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 and CT-scan
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 | NL35440.096.11 |