Survivorship of Attune Primary Total Knee Prosthesis

Noninflammatory Degenerative Joint Disease Clinical Trial

Official title:

Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01754363
• Other study ID #: 10008
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: February 1, 2030

Study information

• Verified date: April 2024
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

Description:

Approximately 30 sites, worldwide, will recruit 1200 patients (1200 knees). Each study site is expected to enroll approximately 50 patients (50 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There is no control group. One thousand two hundred (1200) Subjects will be stratified into 4 subgroups of 300: cruciate retaining fixed bearing(CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP). Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care. This study allowed for enrolment into the study by two methods. The first method was by enroling subjects to receive the implant under study with the expectation to follow them out to 15 years. The second method was done to offset follow-up attrition. The second method allowed additional interested sites that had previously participated in a two-year follow-up study (NCT01746524) on this implant (subjects implanted and followed for two years) to reconsent interested subjects to be further followed out to 15 years in this study. The original 29 sites enroled 1232 subjects. Adding of the interested sites from the 2-yr follow-up study (NCT01746524) increased the sites from 29 to 37 sites. As of the last study update, the current enrolment is now1538.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1542
• Est. completion date: February 1, 2030
• Est. primary completion date: February 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive.
• Subject was diagnosed with NIDJD.
• Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
• Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
• Subject is currently not bedridden.
• Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
• Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
• The devices specified in this protocol were implanted.

Exclusion Criteria:

• Subject is a woman who is pregnant or lactating.
• Contralateral knee has already been enrolled in this study.
• Subject had a contralateral amputation.
• Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
• Subject is currently experiencing radicular pain from the spine.
• Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
• Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
• Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
• Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, etc.).
• Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
• Subject has a medical condition with less than 5 years of life expectancy.

Related Conditions & MeSH terms

• Joint Diseases
• Noninflammatory Degenerative Joint Disease
• Osteoarthritis

Intervention

Device:
• Attune Primary Total Knee Replacement
Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, PS RP).

Locations

Country	Name	City	State
Australia	Canberra Hospital-Trauma & Orthopaedic Research Unit	Adelaide	South Australia
Austria	Krankenhaus der Barmherzigen	Linz	Upper Austria
Austria	Univ.-Klinik für Orthopädie	Vienna	Lower Austria
Belgium	Monica Camputs O.L.V. Middelares	Antwerp
Canada	University of Western Ontario-Department of Orthopaedic Surgery	London	Ontario
Germany	Orthopädische Klinik für die Universität Regensburg	Bad Abbach	Bavaria
Germany	UniversitatsKlinikum Heidelberg	Heidelberg
Hong Kong	Queen Mary Hospital	Hong Kong
Korea, Republic of	Seoul National University Boramae Hospital	Seoul	Dongjak-gu
Korea, Republic of	Seoul National University Hospital	Seoul
Malaysia	University Malaya Medical Centre	Kuala Lumpur
New Zealand	Ascot Hospital	Auckland
Singapore	Singapore General Hospital-Dept of Orthopaedic Surgery	Singapore
Switzerland	Schulthess Klinik	Zurich
United Kingdom	Queen Mary Hospital	Dunfermline	Fife
United Kingdom	New Royal Infirmary of Edinburgh	Edinburgh	Scotland
United Kingdom	Princess Alexandria Hospital	Harlow
United Kingdom	Guys Hospital	London
United Kingdom	Clifton Park NHS Treatment Centre	York
United States	Texas Institute for Hip and Knee Surgery, LLC	Austin	Texas
United States	Orthopedic One	Columbus	Ohio
United States	Florida Research Associates, LLC	DeLand	Florida
United States	Orthopaedic Center of the Rockies	Fort Collins	Colorado
United States	Penn State Hershey Bone & Joint Institute	Hershey	Pennsylvania
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Center for Hip and Knee Surgery	Mooresville	Indiana
United States	OrthoNeuro	New Albany	Ohio
United States	Orthopaedic Specialty Institute	Orange	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Abington Orthopaedic Specialists, PC	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Germany,  Hong Kong,  Korea, Republic of,  Malaysia,  New Zealand,  Singapore,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship of each configuration.	Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).	Minimum 15 years (5414 - 5658 days)
Secondary	Survivorship	Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).	Minimum 5 years (1764 - 3588 days)
Secondary	Survivorship	Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).	Minimum 10 years (3589 - 5413 days)
Secondary	Implant fixation: Radiographic assessment of bone-implant interface performance	Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.	Minimum 1 year (304 - 668 days)
Secondary	Implant fixation: Radiographic assessment of bone-implant interface performance	Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.	Minimum 2 years (669 - 1763 days)
Secondary	Implant fixation: Radiographic assessment of bone-implant interface performance	Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.	Minimum 5 years (1764 - 3588 days)
Secondary	Implant fixation: Radiographic assessment of bone-implant interface performance	Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.	Minimum 10 years (3589 - 5413 days)
Secondary	Implant fixation: Radiographic assessment of bone-implant interface performance	Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.	Minimum 15 years (5414 - 5658 days)
Secondary	Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)	EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.	Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Secondary	Patient-reported Outcome: Oxford Knee Score	The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likert-lie response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.	Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Secondary	Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and includes the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert- like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Secondary	Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)	The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.	Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Secondary	Patient-reported Outcome: Knee Society Score	The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). Likert responses are used, typically with five response options.	Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Secondary	Evaluate the impact of surgeon learning curve on clinical and functional outcomes	A surgeon learning curve will be investigated by comparing learning curve cases (the pooled cohort of each surgeon's first 10 study Subjects) with all investigational Subjects. All primary and secondary outcomes will be compared across the learning curve and post-learning curve Subject cohorts.	<1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Secondary	Evaluate changes in femoral component and tibial component alignment	Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.	Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Secondary	Type and Frequency of Adverse Events (AEs) for all enrolled subjects	All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.	Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).