To verify the uncemented Triathlon Tritanium Knee System safety during follow-up and survivorship as described by Kaplan-Meier survival curves.To document the patient clinical outcome of the patients who have received an uncemented knee arthroplasty…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All adverse events / failures or revision of the Triathlon Tritanium tibia
component
Secondary outcome
Standard clinical parameters (knee society score, KSS) and PROMs (Oxford Knee
Score (OKS), Knee Inury and Osteoarthritis Outcome Score (KOOS), Forgotten
Joint Score (FJS), EuroQol 5D (EQ5D) and Hospital Anxiety Depression Scale
(HADS))
Background summary
Total knee systems consist of a femoral and tibital component with a tibial
baseplate to enhance rotation and flexion. The Triathlon Tritanium knee system
is an uncemented knee system. Tritanium is highly porous metal biologic
fixation technology. improving biological fixation as the three-dimensional
highly porous titanium surface aids bone ingrowth. It is expected to have
similar or even better results concerning early fixation properties and
long-term durability compared to cemented and HA-coated fixation.
The uncemented Triathlon Tritanium is not a new design. The articulating
geometry of the components is identical to the cemented version, as is the
operative technique (obviously, besides the method of fixation) and
postoperative regime. The uncemented Triathlon Tritanium will provide
orthopaedic surgeons a clinically effective alternative to the existing
cemented version with all the advantages of cementless fixation, including
shorter operating and tourniquet times and possibly reduced risk of aseptic
loosening due to an improved biological fixation.
Study objective
To verify the uncemented Triathlon Tritanium Knee System safety during
follow-up and survivorship as described by Kaplan-Meier survival curves.
To document the patient clinical outcome of the patients who have received an
uncemented knee arthroplasty surgery involving a Triathlon Tritanium tibia
component.
Study design
National multicentre, prospective follow-up of a consecutive series of patients
eligible for a knee arthroplasty surgery
Intervention
Implantation of the Triathlon Tritanium Knee System
Study burden and risks
The use of the Triathlon Tritanium Knee System will not increase the risks
compared with the standard used knee system. There are no experimental
procedures. Participation in this study will not affect the medical treatment
of enrolled patients.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
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. Patient eligible and scheduled to undergo primary total knee replacement
with any of the following indications:
- Painful and disabled knee joint resulting from osteoarthritis (Ahlbäck stage
II-V)
- One or more compartments are involved
3. Ability and willingness to follow instructions, including control of weight
and activity level and to return for follow-up evaluations.
4. A good nutritional state of the patient.
5. The patient is a male or non-pregnant female between 40 and 75 years of age.
Exclusion criteria
1. The patient is morbidly obese, defined as Body Mass Index (BMI) of > 37.
2. Previous major knee surgery.
3. Patient 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 > 3 months ago with good outcome can be
included in the study).
4. Patient with other severe concurrent joint involvements that can affect
their outcome.
5. Patient has a flexion contracture of 15 degrees.
6. Patient has a varus/valgus contracture of 15 degrees and more.
7. The patient will be operated bilaterally.
8. The patient has an active or suspected latent infection in or about the knee
joint.
9. Osteomyelitis.
10. The patient has a neuromuscular or neurosensory deficiency, which would
limit the ability to assess the performance of the device.
11. The patient has a systemic or a metabolic disorder leading to progressive
bone deterioration.
12. The patient is immunologically suppressed or receiving steroids in excess
of normal physiological requirements (e.g. > 30 days).
13. Female patients planning a pregnancy during the course of the study.
14. The patient is unable or unwilling to sign the Informed Consent specific to
this study.
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 |
|---|---|
| CCMO | NL66250.098.19 |