ATTUNE Revision Knee System for Total Knee Replacement
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: DePuy Orthopaedics
Must not be taking: Muscular disorder medications
Disqualifiers: Pregnancy, Inflammatory arthritis, Neurological disorders, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial studies the ATTUNE® Revision knee replacement system in patients aged 22-80 with complex knee issues. The system uses customizable parts to improve knee stability and function. The goal is to evaluate how well this system works over time. The ATTUNE Knee System has shown excellent clinical and radiographical outcomes, with a high survival rate.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.
What data supports the effectiveness of the ATTUNE Revision Knee System treatment for total knee replacement?
Research shows that the ATTUNE Knee System, a newer design, may offer better knee movement and tracking compared to older systems like the PFC Sigma. Studies also suggest that it could improve patient satisfaction and function after knee replacement surgery.
12345How is the ATTUNE Revision Knee System treatment different from other treatments for total knee replacement?
The ATTUNE Revision Knee System is unique because it is a second-generation modular system designed to address the challenges of revision knee surgery, offering improved stability, function, and implant longevity compared to standard options. It includes features like offset stems and various levels of constraint to better fit individual patient needs.
24678Eligibility Criteria
This trial is for men and women aged 22-80 who need a complex primary total knee replacement. Participants must be able to understand the study, follow procedures, and not be bedridden. Exclusions include pregnant or lactating women, those with prior knee replacements in the affected leg, inflammatory arthritis diagnoses, spine-related radiating pain, life expectancy under five years due to other medical conditions, recent participation in other clinical trials (last three months), substance abuse history (last five years), severe mobility-limiting muscular disorders like fibromyalgia.Inclusion Criteria
I chose knee replacement with the study device not because of the research.
I have not been diagnosed with any form of inflammatory arthritis.
I am not confined to bed.
+5 more
Exclusion Criteria
Only one of my knees is enrolled in this study for treatment.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months
I am diagnosed with a muscular disorder like fibromyalgia and take prescription medication for it.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo primary total knee arthroplasty using the ATTUNE Revision knee system
6 weeks
1 visit (surgery), follow-up visits as needed
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 2, and 5 years
5 years
Annual visits for assessments
Long-term follow-up
Participants continue to be monitored for long-term outcomes and survivorship of the knee system
5 years
Participant Groups
The ATTUNE Revision Knee System is being tested over five years at multiple centers without randomization or control groups. It involves fixed bearing and rotating platform tibial components with posterior stabilizing femoral components for people undergoing total knee arthroplasty.
1Treatment groups
Experimental Treatment
Group I: ATTUNE Revision knee systemExperimental Treatment1 Intervention
The ATTUNE Revision knees system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
ATTUNE Revision Knee System is already approved in United States for the following indications:
🇺🇸 Approved in United States as ATTUNE Revision Knee System for:
- Severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Colorado Joint ReplacementDenver, CO
University of Mississippi Medical CenterJackson, MS
Dartmouth-Hitchcock Medical CenterLebanon, NH
The Ohio State University Wexner Medical CenterColumbus, OH
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
DePuy OrthopaedicsLead Sponsor
References
Does lucency equate to revision? A five-year retrospective review of Attune and Triathlon total knee arthroplasty. [2023]Label="PURPOSE" NlmCategory="OBJECTIVE">The Attune® total knee arthroplasty system was introduced in 2013 to address lingering issues of patient dissatisfaction. However, recent literature reports concerns of early tibial tray debonding. The aim of this study was to compare the incidence of radiolucent lines, survivorship and patient reported outcome-measures between the Attune® system and the well-established Triathlon® system.
Mid-Term Clinical Outcomes and Survivorship of a Second-Generation Modular Revision Knee System. [2021]Revision knee systems have adapted to the challenges of revision knee arthroplasty with offset stems, augments, cones, and various levels of constraint. The purpose of this study is to review the mid-term outcomes of a second-generation modular knee revision system.
Midterm functional recovery of Total knee arthroplasty patients compared between the ATTUNE knee system and the press fit condylar (PFC) SIGMA knee system. [2021]The ATTUNE Knee System is a new prosthetic design that has theoretical advantages over the Press Fit Condylar (PFC) Sigma Knee System specific to improved knee kinematics and patellofemoral joint tracking. This study aimed to evaluate functional outcomes compared between the ATTUNE and PFC Sigma designs at a minimum follow-up of 5 years.
Short-to-Midterm Outcomes of Revision Total Knee Arthroplasty Patients With a Total Stabilizer Knee System. [2018]Revision total knee arthroplasty (TKA) can often be challenging. The use of a new revision system may aid in providing better stability, improved function, fit, and implant longevity. Therefore, we assessed: (1) survivorship, (2) clinical outcomes, (3) postoperative complications, and (4) radiographic outcomes of patients who underwent revision TKA using this system.
Early and mid-term results with the ATTUNE total knee replacement system compared to PFC Sigma: a prospective comparative study. [2022]Up to 20% of all patients are not satisfied with the result after total knee arthroplasty (TKA). To improve patient satisfaction manufacturers have modified prosthesis design. The ATTUNE prosthesis is a modified version of the PFC Sigma. Aim of this study was to evaluate the outcome at 6 months and 5 years after TKA with ATTUNE compared to PFC Sigma.
The use of a modular rotating hinge component in salvage revision total knee arthroplasty. [2019]Revision total knee arthroplasty (TKA) using a second-generation modular rotating hinge design was performed on 16 knees in 15 patients over a 5-year period. Follow-up of 2 to 6 years (mean, 51 months) was obtained in 14 knees in 13 patients. Indications for revision were aseptic loosening of a hinged prosthesis (8 knees), loosening and bone loss associated with chronic extensor mechanism disruption (2 knees), component instability with chronic medial collateral ligament disruption (3 knees), and comminuted distal femur fracture (1 knee). Clinical and radiographic results were reviewed and compared with 87 patients who underwent revision TKA using a standard condylar revision design during the same period. Early results showed comparable postoperative knee scores and range of motion between the 2 groups despite the use of the rotating hinge component in more complex revision cases. No patient has exhibited radiographic evidence of definite component loosening. Alignment of 5 degrees to 10 degrees of valgus in the frontal plane and within 2 degrees of neutral in the sagittal plane was achieved consistently. Short-term clinical and radiographic results are encouraging and suggest that a second-generation modular rotating hinge component can be used successfully in selected salvage revision cases.
Implant survivorship, functional outcomes and complications with the use of rotating hinge knee implants: a systematic review. [2022]With more complex primary and revision total knee arthroplasty procedures there is often the need to use more constrained prostheses. This study aims to investigate patient-relevant outcomes following primary and revision rotating-hinged total knee arthroplasty.
Revision after total knee arthroplasty. [2004]Revision of a total knee arthroplasty is most frequently required because of prosthetic loosening, instability, and failure to restore proper axial alignment. The instability and improper axial alignment may result in abnormal stresses that predispose to component loosening, component failure, and stress fracture of the tibia. Therefore, it is essential to obtain correct axial alignment and soft tissue balance at the time of the initial arthroplasty. Approximately two thirds of those knees having one or more revisions of their arthroplasty will have a satisfactory result. One third will have an unsatisfactory result related to continued pain or restricted motion, or both. We have reported the results in 142 knees, 95 of which had one revision, 37 of which had two revisions, and 10 of which had three revisions. It is essential in such revisions, in our opinion, to thoroughly debride the knee, restore quadriceps balance, establish the correct alignment, minimize bone loss, and use the least possible constraint in the prosthesis combined with an external brace for three to six months.