Primary objectives:- Investigate the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE Primary, Cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigate the change from pre-operative baseline to two year postoperative
functional performance improvement for the ATTUNE Primary, Cementless TKA RP
system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will
be carried out for two configurations: cruciate retaining rotating platform
(ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE
Cementless PS RP).
Secondary outcome
Evaluate change from preoperative baseline in post-operative outcomes using
additional patient reported measures at 2 years: PKIP (overall and sub-scores),
KOOS (overall and sub-scores), AKS and EQ-5D-3L.
- Evaluate change from preoperative baseline in pain and satisfaction over time
as measured using a modified VAS Pain Score (discrete numbers rather than a
continual scale) at 2yr.
- Evaluate type and frequency of Adverse Events
- Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR
RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and
5yrs.
- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic
analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial
component alignment at 2 years compared to the first postoperative radiographs.
Background summary
The ATTUNE Knee System was introduced in 2011 with a goal of addressing the
unmet needs of patients, surgeons,
and hospital providers, initially as a cemented system. The goals were to
improve function and advance surgical
processes. Some surgeons prefer to treat their patients with a cementless
fixation system so the ATTUNE
Cementless Total Knee System has been developed to address their needs.
Study objective
Primary objectives:
- Investigate the change from pre-operative baseline to two year postoperative
functional performance improvement for the ATTUNE Primary, Cementless TKA RP
system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will
be carried out for two configurations: cruciate retaining rotating platform
(ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE
Cementless PS RP).
Secondary objectives:
- Evaluate change from preoperative baseline in post-operative outcomes using
additional patient reported measures at 2 years: PKIP (overall and sub-scores),
KOOS (overall and sub-scores), AKS and EQ-5D-3L.
- Evaluate change from preoperative baseline in pain and satisfaction over time
as measured using a modified VAS Pain Score (discrete numbers rather than a
continual scale) at 2yr.
- Evaluate type and frequency of Adverse Events
- Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR
RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and
5yrs.
- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic
analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial
component alignment at 2 years compared to the first postoperative radiographs.
Tertiary objectives:
- Evaluate change from preoperative baseline in post-operative outcomes using
additional patient reported measures at 6wk, 6mo, 1yr, and 5yr: PKIP (overall
and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L .
- Evaluate the change from pre-operative baseline in pain and satisfaction as
measured using a modified VAS Pain Score (discrete numbers rather than a
continual scale) at 6wk, 6mo, 1yr and 5yr.
- Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR
RP and PS RP configurations using Kaplan-Meier survival analysis at 6mo and 1yr.
- Evaluate correlations between PKIP and each of the following: KOOS (overall
and sub-scores) and AKS
- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic
analysis of the bone-implant interface at 5yrs after surgery.
- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial
component alignment at 5 years compared to prior postoperative radiographs.
- Evaluate the impact of pre-operative attitude to pain, assessed using the
Pain Catastrophizing Scale, on the post-operative pain profile and
post-operative satisfaction at 6wk, 6mo, 1yr, 2yr and 5yr.
- Evaluate the functional outcome (KOOS ADL at all time-points post-op) as a
function of posterior cruciate ligament treatment within the CR RP cohort.
- Evaluate the duration of surgery (*skin- to skin* time)
- Evaluate correlations between radiographic interface analysis and patient
reported VAS pain and investigator-reported adverse events for severe pain.
Study design
Prospective, multi-center, non-randomized, non-controlled design. Level of
evidence: Level II
Study burden and risks
- Pre and post operatively follow up visits. The patient needs to complete some
patient reported outcome instruments (Questionnaire eg KOOS-PS, PKIP, EQ5D,
pain catastrophizing scale and subject knee outcome. Pre and post operatively
visits with AP and lateral X Ray
- Xray AP and lateral will be taken at pre operatively, 6 Weeks, 6 Months, 1
year, 2 year and 5 year. Three visit s have Xray as standard of care and two
are outside the standard of care.
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) Subject was diagnosed with NIDJD and in the opinion of the Investigator,
their condition is consistent with the indications detailed in the Instructions
For Use.
c) Subject, in the opinion of the Investigator, is a suitable candidate for
cementless primary TKA using the devices described in this CIP with either
resurfaced or non-resurfaced patellae.
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 PROs in either English or one of the available
translations.
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, bicompartamental or
patellofemoral joint replacement), patellectomy, high tibial osteotomy 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 their
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 (e.g., muscular
dystrophy, multiple sclerosis, Charcot disease).
k) Subject is suffering from inflammatory arthritis (e.g., rheumatoid
arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus
erythematosus, etc.).
l) Subject has a medical condition with less than five (5) years life
expectancy.
m) 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 | NCT02839850 |
| CCMO | NL60626.100.17 |