Attune Cementless Knee Replacement for Osteoarthritis
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Canadian Radiostereometric Analysis Network
No Placebo Group
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.
What data supports the idea that Attune Cementless Knee Replacement for Osteoarthritis is an effective treatment?The available research shows that the Attune Cementless Knee Replacement is effective, with a study reporting excellent results in 68.1% and good results in 29.8% of cases. Additionally, the survivorship rate, which indicates how long the knee replacement lasts without needing further surgery, was 98.3% at 10 and 18 years. This suggests that the Attune Cementless Knee Replacement is a reliable option for treating osteoarthritis, with a high percentage of patients experiencing positive outcomes over a long period.147810
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications.
Is the Attune Cementless Knee Replacement a promising treatment for osteoarthritis?Yes, the Attune Cementless Knee Replacement is a promising treatment for osteoarthritis. Studies show that cementless knee replacements have high success rates, with excellent and good results in most cases. They also have a high survival rate, meaning they last a long time without needing further surgery.23456
What safety data exists for the Attune Cementless Knee Replacement?The Attune Cementless Knee Replacement has been evaluated in various studies. A five-year retrospective review compared the Attune system with the Triathlon system, focusing on radiolucent lines, survivorship, and patient-reported outcomes. The New Jersey Low Contact Stress Rotating Platform Knee Replacement, which includes cementless options, showed excellent and good results in long-term follow-ups, with stable fixation and minimal complications. The ATtune Knee Outcome Study is a multicenter prospective evaluation of the uncemented Attune system, aiming to assess revision rates, complications, and patient outcomes. Overall, the available data suggests that the Attune Cementless Knee Replacement has a good safety profile with high survivorship and satisfactory clinical outcomes.134910
Eligibility Criteria
This trial is for individuals with osteoarthritis who are candidates for total knee replacement surgery. Specific eligibility criteria to participate in the study have not been provided, so interested patients should contact the study organizers for more information.Inclusion Criteria
I need a knee replacement due to severe arthritis pain.
I am 21 years old or older.
Exclusion Criteria
My posterior cruciate ligament is damaged.
I have no health conditions that the treatment's guide says should avoid it.
I have a type of joint inflammation.
I cannot undergo major surgery due to my health condition.
I need surgery for bone defects using specific implants.
I have had an infection in the same limb as my current condition.
Participant Groups
The trial is evaluating a specific type of knee replacement called the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System. It's being tested at multiple centers and involves patients receiving this particular implant during their surgery.
1Treatment groups
Experimental Treatment
Group I: Attune Cementless, Fixed Bearing, Cruciate Retaining TKA SystemExperimental Treatment1 Intervention
Attune Cruciate Retaining TKA System
Attune Cementless is already approved in United States, European Union, Japan, Australia for the following indications:
🇺🇸 Approved in United States as ATTUNE Cementless Knee for:
- Total knee replacement for osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant
🇪🇺 Approved in European Union as ATTUNE Cementless Knee for:
- Total knee replacement for osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant
🇯🇵 Approved in Japan as ATTUNE Cementless Knee for:
- Total knee replacement for osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant
🇦🇺 Approved in Australia as ATTUNE Cementless Knee for:
- Total knee replacement for osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Orthopaedic Innovation CentreWinnipeg, Canada
Nova Scotia Health - OrthopedicHalifax, Canada
London Health Sciences CentreLondon, Canada
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Who is running the clinical trial?
Canadian Radiostereometric Analysis NetworkLead Sponsor
References
The New Jersey Low-Contact-Stress Knee Replacement System: biomechanical rationale and review of the first 123 cemented cases. [2019]A mobile-bearing element, metal-backed, interchangeable knee replacement system has been designed to combine low constraint forces with low contact stresses (LCS), allowing nearly normal joint articulation and loading as well as long-term wear resistance of the implants. The system is versatile, including a large number of component options in variable sizes, and it may be used in both primary and revision arthroplasties. The overall results in the first 123 cemented cases (97 patients) with 2- to 7-year follow-up (average 3.7 years) were good to excellent in 88.6%, fair in 3.3%, and poor in 8.1%. Fair and poor results were seen predominantly in multiply operated and implant revision cases. The best results were noted in primary cases, 97.4% of which had good to excellent results. There have been no mechanical implant failures and no meniscal bearing dislocations in this series. Pain relief and restoration of function have been very gratifying with this system.
Results of 1,000 Performance knees: cementless versus cemented fixation. [2019]A total of 893 patients with 1,000 Performance total knee prostheses were retrospectively studied. The mean follow-up was 5.2 years. In 584 cases, the femoral and tibial components were implanted using cementless techniques, and in 416 knees the femoral and tibial components were cemented. All patients received a cemented all polyethylene patellar replacement. Tibial bone density determined fixation type. The average age of patients with cementless fixation was 64.3 years versus 76.2 years for patients with cemented implants. The average subjective and functional Knee Society scores were 91.2 and 90.1 for patients with cementless knees and 89.6 and 83.5 for those with cemented replacements. A surprising absence of osteolysis around screw fixation was noted, and at 5 years, there was 99% implant survival.
Twenty-year evaluation of meniscal bearing and rotating platform knee replacements. [2019]Clinical results of the initial cemented and cementless series of 373 New Jersey Low Contact Stress total knee replacements in 282 patients surviving at least 10 years were analyzed using a strict knee scoring scale. The study showed excellent, good, fair, or poor results in 68.1%, 29.8%, 2.1%, or 0% of primary posterior cruciate-retaining meniscal bearing knee replacements, 46.7%, 53.3%, 0%, or 0% results in primary cemented rotating platform knee replacements, and 68.1%, 29.8%, 2.1%, or 0% results in primary cementless rotating platform knee replacements, respectively. Radiographic evaluation at minimum 10-year followup showed stable fixation of all components, no gross migration but significant osteolysis requiring bearing exchange and bone grafting in three cementless rotating platform knee replacements (1.8%) in three patients who underwent previous surgeries at an average of 10.2 years from the index surgery. Survivorship of the patients who underwent primary cementless posterior cruciate-retaining meniscal bearing knee replacements with an end point of revision for any mechanical reason was 97.4% at 10 years and 83% at 16 years; using an end point of a poor clinical knee score the survivorship was 98.9% at 10 years and at 16 years. Survivorship of the patients who underwent primary cemented rotating platform knee replacements with end points of revision for any mechanical reason or a poor clinical knee score was 97.7% at 10 years and at 20 years. Survivorship of the patients who underwent cementless rotating platform knee replacements with end points of revision for any mechanical reason or a poor clinical knee score was 98.3% at 10 years and at 18 years.
Twenty-year evaluation of the New Jersey LCS Rotating Platform Knee Replacement. [2022]Clinical results of the initial cemented and cementless series of 233 New Jersey Low Contact Stress Rotating Platform Knee Replacements in 184 patients surviving at least 10 years were analyzed using a strict knee scoring scale. The study showed excellent (46.7%) and good (53.3%) results in primary cemented rotating platform knee replacements, and excellent (68.1%), good (29.8%), and fair (2.1%) results in primary cementless rotating platform knee replacements. Radiographic evaluation at a minimum 10-year follow-up showed stable fixation of all components, no gross migration but significant osteolysis requiring bearing exchange, and bone grafting in three cementless rotating platform knee replacements (1.8%) in three patients who underwent previous surgeries at an average 10.2 years from the index surgery. Survivorship of the patients who underwent primary cemented rotating platform knee replacements with end points of revision for any mechanical reason or a poor clinical knee score was 97.7% at 10 and 20 years. Survivorship of the patients who underwent cementless rotating platform knee replacements with end points of revision for any mechanical reason or a poor clinical knee score was 98.3% at 10 and 18 years.
Long-term followup after mobile-bearing total knee replacement. [2019]Clinical and radiographic analyses and survivorship were done on the initial cementless series of 309 posterior cruciate-retaining meniscal-bearing and rotating-platform New Jersey LCS total knee replacements followed up for 10 to 20 years (mean, 12.4 years). Clinical results in patients surviving at least 10 years using a strict knee scoring scale were similar for posterior cruciate ligament-retaining and posterior cruciate ligament-sacrificing designs. Good to excellent results were seen in 97.9% of primary posterior cruciate-retaining-bearing prostheses and in 97.9% of primary rotating-platform prostheses. Radiographic analysis of minimum 10-year followup radiographs showed generally stable fixation of all components with gross migration seen in one tibial component (0.6%) in a patient with a failed high tibial osteotomy. Significant osteolysis was present requiring bearing exchange and bone grating in three patients with cementless rotating-platform prostheses (1.8%) who had multiple knee surgeries at an average of 10.2 years from the index surgery. Survivorship of the primary cementless posterior cruciate-retaining meniscal-bearing prostheses with an end point of revision for any mechanical reason was 97.4% at 10 years and 83% at 16 years; using an end point of a poor clinical knee score, the survivorship was 98.9% at 10 and 16 years, respectively. Survivorship of the primary cementless rotating-platform prostheses with end points of revision for any mechanical reason or a poor clinical knee score was 98.3% survivorship at 10 and 18 years, respectively. In the current study, no cementless rotating-bearing patella loosened, fractured, or dissociated in patients without prior knee surgery although one cementless rotating-bearing patella (0.6%) in a patient who had multiple knee surgeries wore through the inferior marker wire after 10.8 years, causing metallosis that required revision.
Survival analysis of a cementless, cruciate-retaining total knee arthroplasty. Clinical and radiographic assessment 10 to 13 years after surgery. [2019]We performed a prospective study of 54 patients (76 knees) who underwent Osteonics series 3000 cruciate-retaining cementless total knee arthroplasty between December 1990 and June 1993. Five patients (seven knees) were lost to follow-up (90.7% completion). One patient required revision at 10.5 years after operation. The rate of survival was 100% at ten years and 96.7% at 13 years. The mean ten-year knee and function scores were 79 and 59 respectively. Both were significantly better than the pre-operative scores. The range of movement also improved. Although a radiolucent line around the tibial component enlarged in six knees (20.7%) at ten years, the clinical outcome was generally good. In a patient who died after 5.5 years, post-mortem examination of the knee showed no bony ingrowth into the tibial component. Despite poor bony ingrowth, press-fit fixation was satisfactory and good results can be obtained with this cementless, cruciate-retaining prosthesis.
Has the modern design of Attune total knee replacement improved outcome in patients with isolated patellofemoral arthritis? [2021]Modern knee replacements aim to improve patient function in arthritis affecting different compartments of the knee. This study evaluates the Patient Reported Outcome Measure (PROM) and functional outcome of a modern total knee replacement (Attune, DePuy) in patients with isolated patellofemoral arthritis.
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.
Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system. [2021]Total Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). Even though providing satisfactory results for the majority of patients, some studies report dissatisfaction after TKA to be as high as 20%. Among other things, pain catastrophising and self-efficacy are thought to compromise results of TKA. Implant manufacturers keep improving upon their designs in an attempt to improve functional outcomes. One of these novel knee systems is the Attune. To our knowledge, there are no clinical follow-up studies reporting results of the uncemented version. The main objective of this multicentre prospective observational study is to evaluate revision rate, complications, radiographic outcomes (i.e. alignment and radiolucent lines) and patient reported outcomes of the uncemented Attune mobile bearing TKA. Secondary objectives are (1) to assess physical function, return to sport and return to work after TKA and (2) to evaluate the long-term effect of preoperative psychological factors on satisfaction after TKA.
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.