Primary Objective There are two co-primary objectives; one regarding each tibial component configuration, fixed bearing (FB) and rotating platform (RP): 1) Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective
There are two co-primary objectives; one regarding each tibial component
configuration, fixed bearing (FB) and rotating platform (RP):
1) Evaluate change from preoperative baseline to the 2 yr timepoint in patient
reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB
configuration.
2) Evaluate change from preoperative baseline to the 2 yr timepoint in patient
reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA RP
configuration.
Secondary outcome
The secondary objectives of this study are:
* Evaluate change from preoperative baseline to the 5 yr timepoint in
functional outcomes as measured using KOOS patient reported outcomes measure
(PROM).
• Evaluate change from preoperative baseline to the 5 yr timepoint in
functional outcomes and quality of life assessments, as measured using patient
reported outcomes measures (PROMS) : PKIP (overall and sub-scores), AKS 2011
(Subject evaluations) and EQ-5D-5L.
• Evaluate change from preoperative baseline to the 5 yr timepoint in patient
reported pain severity as measured using a modified VAS Pain Score (discrete
numbers rather than a continual scale).
• Evaluate change from preoperative baseline to the 5 yr timepoint in patient
reported satisfaction over time as measured using a Likert scale.
• Estimate the change from preoperative baseline to the 5 yr timepoint in
clinical outcomes using the 2011 AKS (surgeon evaluation)
• Evaluate type and frequency of Adverse Events
• Evaluate the timing, duration and reason for any readmissions stratified by
adverse event type (operative site vs. systemic).
• Evaluate annual survivorship of the ATTUNE® Revision in complex primary TKA
system for the FB and RP configurations and the combined FB and RP
configurations using Kaplan-Meier survival analysis at 1, 2, 3, 4 and 5 years.
• Evaluate component*s fixation in complex primary TKA through zonal
radiographic analysis of the femoral, tibial and patellar bone-implant
interface at 1, 2 and 5 years after surgery compared to the first postoperative
radiographs.
• Evaluate any changes in anatomic tibiofemoral, femoral component, tibial
component and patellar component alignment at 1, 2 and 5 years compared to the
first postoperative radiographs.
• Radiographically evaluate the restoration of joint line using the first
postoperative radiographs according to the methodology of Figgie8
Background summary
The ATTUNE Revision system is new and without pre-existing clinical data. It is
therefore important to conduct a post-market study to evaluate the short/medium
term clinical performance and medium term survivorship of the implant system,
which includes instrumentation, in complex primary TKA. In particular, this
study will provide opportunities for active post-market surveillance of adverse
effects in relation to use of the study device as well as providing both the
patient*s and clinician*s perspectives of implant performance. Furthermore, an
independent analysis of the study radiographs will provide unbiased and
consistent data across the entire study population. Overall the study will
result in a comprehensive dataset that will form the baseline for this
implant*s medium term performance in the included population.
Study objective
Primary Objective
There are two co-primary objectives; one regarding each tibial component
configuration, fixed bearing (FB) and rotating platform (RP):
1) Evaluate change from preoperative baseline to the 2 yr timepoint in patient
reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB
configuration.
2) Evaluate change from preoperative baseline to the 2 yr timepoint in patient
reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA RP
configuration.
Study design
This study is designed as a prospective, multi-center, non-randomized,
non-comparative, non-controlled study. Level of evidence: III.
Study burden and risks
Subjects would be having a TKA regardless of their participation in the study
and !here are risks associated with surgery (which are detailed in the
protocol) but these risks are not specific tor participation in this study.
- Pre and post operatively follow up visits. The patient needs to complete some
patient reported outcome instruments (Questionnaire ).
- Xray AP and lateral and skyline will be taken at pre operatively, 6 Weeks, 1
year, 2 year and 5 year.
Orthopaedic Drive 700
Warsaw 46581-0988
US
Orthopaedic Drive 700
Warsaw 46581-0988
US
Listed location countries
Age
Inclusion criteria
a) Subject is male or female and between the ages of 22 and 80 years at the
time of consent, inclusive.
b) The decision to have knee replacement with the study device is regardless of
the research.
c) The devices are to be used according to the approved indications.
d) Subject that is willing to give voluntary, written informed consent to
participate in this clinical investigation and authorize the transfer of
his/her information to the Sponsor.
e) Subject is currently not bedridden.
f) Subject, in the opinion of the Investigator, is able to understand this
clinical investigation and is willing and able to perform all study procedures
and follow-up visits and co-operate with investigational procedures.
g) Subject is able to read, and comprehend the Informed Consent Document as
well as complete the required PROMs in either
English or one of the available translations.
h) Subject has not been diagnosed with an inflammatory arthritis (including
gout, rheumatoid, psoriatic etc.)
Exclusion criteria
a) The Subject is a woman who is pregnant or lactating.
b) Contralateral knee has already been enrolled in this study.
c) Subject had a contralateral amputation.
d) Previous partial knee replacement (unicompartmental, bicompartmental or
patellofemoral joint replacement) or primary TKA in affected knee.
e) Subject is currently diagnosed with radicular pain from the spine that
radiates into the limb to receive TKA.
f) Subject has participated in a clinical investigation with an investigational
product (drug or device) in the last three (3) months.
g) Subject is currently involved in any personal injury litigation,
medical-legal or worker*s compensation claims.
h) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in
the last 5 years) or has a psychological disorder that could affect his/her
ability to complete patient reported questionnaires or be compliant with
follow-up requirements.
i) Subject was diagnosed and is taking prescription medications to treat a
muscular disorder that limits mobility due to severe stiffness and pain such as
fibromyalgia or polymyalgia.
j) Subject has a significant neurological or musculoskeletal disorder(s) or
disease that may adversely affect gait or weight bearing activities (e.g.,
muscular dystrophy, multiple sclerosis, Charcot disease).
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 |
|---|---|
| ClinicalTrials.gov | NCT03153449 |
| CCMO | NL62595.068.17 |