The primary purpose of this study is to compare alignment criteria in the Oxford Partial Knee using conventionalinstrumentation and Signature Custom Guides.Secondly it is questioned whether the Signature technology can reduce the number of surgical…
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 600
Dordrecht 3316LC
NL
Toermalijnring 600
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
-Patients incapable of following directions regarding rehabilitation
-Patients who refuse, cannot, or should not receive a CT or MRI.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL47831.098.14 |