There are two, co-primary objectives; one regarding each tibial component FB or RP:1) To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There are two, co-primary objectives; one regarding each tibial component FB or
RP:
1) To evaluate the 5 year survivorship using Kaplan-Meier survival analysis,
with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS
FB configuration.
2) To evaluate the 5 year survivorship using Kaplan-Meier survival analysis,
with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS
RP configuration.
Secondary outcome
• Evaluate change from preoperative baseline to 2 and 5 yr timepoints in
functional outcomes and quality of life assessments, as measured using patient
reported outcomes measures (PROMS) : PKIP (overall and sub-scores), KOOS -
Physical Function Shortform,(PS), AKS 2011 (Subject evaluations) and EQ-5D-5L.
• Evaluate change from preoperative baseline to 2 and 5 yr timepoints 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 2 and 5 yr timepoints in
patient reported satisfaction as measured using a Likert scale.
• Estimate the change from preoperative baseline to 2 and 5 yr timepoints 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 survivorship of the ATTUNE® Revision TKA system for the PS FB and PS
RP configurations and the combined PS FB and PS RP configurations using
Kaplan-Meier survival analysis at 1, 2, 3, and 4 years.
• Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of
the 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 and tibial
component alignment at 1, 2 and 5 yrs compared to the first postoperative
radiographs.
• Radiographically evaluate the restoration of joint line using the first
postoperative radiographs according to the methodology of Figgie.
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 medium term
survivorship and short/medium term clinical performance of the implant system,
which includes instrumentation. 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
There are two, co-primary objectives; one regarding each tibial component FB or
RP:
1) To evaluate the 5 year survivorship using Kaplan-Meier survival analysis,
with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS
FB configuration.
2) To evaluate the 5 year survivorship using Kaplan-Meier survival analysis,
with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS
RP configuration.
Study design
Prospective, multi-center, non-randomized, non-controlled design. Level of
evidence: Level III
Study burden and risks
Subjects would be having a TKA regardless of their participation in the study
and there are risks associated with surgery (which are detailed in the
protocol) but these risks are not specific for participation in this study.
- Pre and post operatively follow up visits. The patient needs to complete some
patient reported outcome instruments (Questionnaire ).
- Pre and post operatively visits with AP, lateral and skyline X Ray
- 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
* Subject is male or female and between the ages of 22 and 80 years at the time
of consent, inclusive.
* Subject presents with a primary knee arthroplasty (primary TKA,
unicompartmental) or prior revision TKA that requires a revision procedure of
implanted tibial and/or femoral components.
* The decision to perform a knee revision with the study device is regardless
of the research.
* 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
* Subject is currently not bedridden
* The devices are to be used according to the approved indications.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.
Exclusion criteria
* The Subject is a woman who is pregnant or lactating.
* Contralateral knee has already been enrolled in this study.
* Subject had a contralateral amputation.
* Subject is currently diagnosed with radicular pain from the spine that
radiates into the limb to receive RTKA.
* Subject has participated in a clinical investigation with an investigational
product (drug or device) in the last three (3) months.
* Subject is currently involved in any personal injury litigation,
medical-legal or worker's compensation claims.
* 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.
* 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.
* 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).
* Subject has a medical condition with less than five (5) years life expectancy
as determined by the Investigator.
* Uncontrolled gout
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 | NCT03153475 |
| CCMO | NL62152.068.17 |