The primary purpose of this study is to compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides. Secondly it is questioned whether the Signature technology can reduce the number of…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint: To determine the accuracy and precision of Signature Guides
in the Oxford Knee by the percentage of knees achieving optimal alignment
Secondary outcome
Secondary Endpoint: Average Number of Instrument Cases Used
In addition, clinical outcomes and cost efficiency data will be collected to
develop economical models.
Background summary
Recently, the Signature Custom Guide technology was introduced in total knee
arthroplasty. Instead of using an x-ray, the preoperative plan is created by an
MRI that is uploaded to a software system so that the surgeon can plan the case
preoperatively while seeing the entire knee and leg (not obscured by soft
tissue) on their computer screen prior to surgery. Using the planning software,
a custom guide is created to align pins used to secure traditional cutting
blocks while performing distal femoral and proximal tibial cuts.
By using patient specific guides it is hoped to reduce the number of outliers
in placement of the uni knee. Further it is questioned what is the influence of
high versus low volume users with this technique.
Study objective
The primary purpose of this study is to compare alignment criteria in the
Oxford Partial Knee using conventional instrumentation and Signature Custom
Guides.
Secondly it is questioned whether the Signature technology can reduce the
number of surgical instruments needed during surgery.
Overall, the intent is to collect the performance and clinical outcomes of the
Oxford Partial Knee System using Signature Custom Guides or Conventional
Instrumentation to develop economical models.
Study design
Prospective Multi-Center Randomized Two Armed Trial
Intervention
placement of the unicompartmental knee (Oxford) with Signature (patient
specific instrumentation) compared to traditional instruments
Study burden and risks
Because two routine ways to perform Unicompartmental knee replacement with the
Oxford are compared and only one additional CT scan is made to objectify the
outline of the prosthesis placement is determined, the burden for the patient
is limited.
Toermalijnring 100
Dordrecht 3316LC
NL
Toermalijnring 100
Dordrecht 3316LC
NL
Listed location countries
Age
Inclusion criteria
- Individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease.
- Patients 21 and over.
Exclusion criteria
- Active Infection, sepsis or osteomyelitis
- Use of prosthesis in lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- revision of failed prosthesis, failed upper tibial osteotomy, or post traumatic arthritis after tibial plateau fracture
- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device.
- Disease or damage to the lateral compartment of the knee
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Poor bone quality / known osteoporosis
- Metabolic disorders (which may impair bone formation)
- Osteomalacia
- Distant foci of infections which may spread to implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
- Vascular insufficiency, muscular atrophy, neuromuscular disease.
- Incomplete or deficient soft tissue surrounding the knee.
- Charcot*s disease
- A fixed varus deformity (not passively correctable) of greater than 15 degrees
- A flexion deformity greater than 15 degrees.
- Non-staged Bilateral patients
- Patients who refuse, cannot, or should not receive a CT or MRI. Since patients are randomized into treatment groups, all patients must be able to receive an MRI (should follow local MRI screening protocol). This excludes patients who have metal artifacts in the knee, patients who are too large to fit into the knee coil, patients with pacemakers, patients unable to lie still for the duration of the MRI, and patients who are claustrophobic.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 |
|---|---|
| ClinicalTrials.gov | NCT01763684 |
| CCMO | NL45815.098.13 |