The objective of this study is to collect basic function and patient satisfaction datafor observation and analysis.Specific objectives include the following:Evaluate the effect of component design on functional performance by comparing…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. clinical evaluation: preoperative, peri-oprative, potopreative prior to
discharge and follow-up
2. patient scores:
KOOS (Knee injury and osteoarthritis outcome score) and SF-36 for patient
satisfaction
LEAS (Lower Extemety Activity Scale) for patient activity
EQ5D (Quality of Life)
Secondary outcome
see primary parameters
Background summary
This document is a protocol for a clinical outcome study. This study will be
conducted in
compliance with the protocol, Good Clinical Practice Guidelines, associated
regulations and all
applicable research requirements.
Today total knee joint replacements are routinely implanted with total knee
arthroplasty being
one of the most successful joint reconstructions. The number of total knee
replacements is
rising worldwide and patients are increasingly younger at the time of
implantation. The
developments of the implant design, as well as the improvement of instruments,
over the last
decades enable sound and reliable results. With increasing success of joint
replacement and
decreasing age of patients, the expectations of total knee arthroplasty are
constantly on the rise.
Patients anticipate reduced painkiller, long lifetime of the implant with high
functionality and a
great range of motion to carry out daily activities and sports. Apart from
regaining a lifestyle
without major knee pain, some cultural and religious aspects (e.g. kneeing
while praying) where
deep flexion is required, are a challenge for modern knee-systems.
The Scorpio NRG® Knee System has been designed with these activities in mind.
Scorpio
NRG® has a greater internal and external rotational freedom throughout the full
range of motion
when compared to other modern knee replacement designs. Traditional insert
designs utilize a
less functional partial rotary arc, thus limiting the overall kinematic
function of the knee. The
Scorpio NRG® tibial insert*s articulating surface uses a Spherical Arc motion
in order to realize
greater freedom. By combining a single M/L radius and a Spherical Arc, Scorpio
NRG® allows
for greater rotational freedom without restricting the tibio-femoral contact
area. Freedom of
rotation is one of the most essential factors in the design of a successful
total knee replacement,
thus allowing the patient*s ligaments to govern motion of the knee.
Furthermore the component design can contribute to patient*s activity level by
providing joint
stability and improved function. While traditional knee implants are designed
with several axes
of rotation that may create mid-flexion instability during the transition
between radii, a single axis
and single radius design can provide consistent collateral ligament isometry
and stability
throughout the range of motion.
In this outcome study of the Scorpio NRG® knee system we except improvement of
a patients
lifestyle and activities. This study evaluates patients for 5 optional 7 years
post surgery. The
focus of this study is to evaluate the effect of component design on functional
performance and
the patient*s satisfaction. Thus the knee society score and the SF-36 is used.
Further measure
being used includes the comparative postoperative with preoperative Lower
Extremity Activity
Scale (LEAS) and in addition the Knee Injury and Osteoathritis Outcome Score
(KOOS) and EQ5D to
evaluate the quality of life.
Study objective
The objective of this study is to collect basic function and patient
satisfaction data
for observation and analysis.
Specific objectives include the following:
Evaluate the effect of component design on functional performance by comparing
postoperative
Knee Society Scores with preoperative.
Evaluate the effect of component design on patient activity by comparing
postoperative Lower
Extremity Activity Scale (LEAS) with preoperative.
Evaluate patient satisfaction using SF-36® Health Survey.
Evaluate quality of life using Knee Injury and Osteoathritis Outcome Score
(KOOS) and EQ5D.
Study design
A prospective, open-label design will be employed. The study is international
and multicentre.
Study burden and risks
As in any surgical procedure, certain risks are associated with total joint
arthroplasty. These risks include but are not limited to: anaesthetic ans post
anaestehtic reactions (such as hyperaemiea), allergic reactions to prophylactic
antibiotics or blood transfusions, damage to blood vessels or nerves,
trochanteric or femoral fractures during implantation,perforation of the
cortical wall, or death. Post-operatively, a patient may experience
thrombophlebitis, pulmonary embolus, disklocation, pain, limp, component
loosening, osteolysis due to wear debris or the need for additional surgery.
Fracture of the prosthesis is a potential complication.
Pre-clinical, clinical and mechanical testing of the used implants indicate
that the above mentioned risks should not occur at a rate greater than that for
any other type of total knee arthroplasty reported in the literature.
Corporate Drive 325
New Jersey NJ 07430
US
Corporate Drive 325
New Jersey NJ 07430
US
Listed location countries
Age
Inclusion criteria
1) Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form.;2) The subject is a male or non-pregnant female between 40 and 75 years of age.;3) The subject requires a primary total knee replacement.;4) Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis);5) The subject has intact collateral ligaments.;6) The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.;7) The subject is capable of understanding the patient scores in the national language.
Exclusion criteria
1) The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.;2) The subject has a history of total or unicompartmental reconstruction of the affected joint.;3) The subject will be operated bilaterally.;4) Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).;5) Patients who had a Total Knee Arthroplasty (TKA) on contralateral
side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).;6) Patients who will need lower limb joint replacement for another joint within one year.
7) The subject has had a high tibial osteotomy or femoral osteotomy.;8) The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.;9) The subject has a systemic or metabolic disorder leading to progressive bone deterioration.;10) The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.;11) The subject*s bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.;12) The subject has had a knee fusion to the affected joint.;13) The subject has an active or suspected latent infection in or about the knee joint.;14) Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition).;15) Female patients planning a pregnancy during the course of the study.;16) The subject is a prisoner.;17) severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur
> 20 degree, as well as 10 degrees flexion contracture
Design
Recruitment
Medical products/devices used
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 | NL25443.100.08 |