History of Changes for Study: NCT01754363

Survivorship of Attune Primary Total Knee Prosthesis

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Study Record Versions

Version	Submitted Date	Changes
1	December 18, 2012	None (earliest Version on record)
2	February 27, 2013	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	August 19, 2013	Contacts/Locations and Study Status
4	February 28, 2014	Contacts/Locations and Study Status
5	April 11, 2014	Study Status
6	July 14, 2014	Contacts/Locations and Study Status
7	July 29, 2014	Study Status
8	January 15, 2015	Contacts/Locations and Study Status
9	June 5, 2015	Study Status
10	July 27, 2015	Recruitment Status, Study Status and Contacts/Locations
11	May 27, 2016	Study Status
12	January 27, 2017	Study Status
13	February 27, 2017	Study Status and Study Design
14	April 24, 2017	Study Status and Contacts/Locations
15	December 4, 2017	Study Status
16	January 2, 2019	Study Status
17	June 19, 2019	Study Status and Contacts/Locations
18	December 20, 2019	Study Design, Contacts/Locations, Study Status, Arms and Interventions and Study Description
19	May 18, 2020	Study Status, Contacts/Locations and Study Design
20	July 13, 2021	Study Design, Oversight, Contacts/Locations, Study Status and Arms and Interventions
21	October 4, 2021	Study Status
22	November 1, 2021	Study Status
23	December 28, 2021	Study Status
24	January 24, 2022	Study Status
25	February 21, 2022	Study Status
26	March 21, 2022	Study Status
27	April 18, 2022	Study Status
28	May 16, 2022	Study Status
29	June 13, 2022	Study Status
30	July 11, 2022	Study Status
31	August 8, 2022	Study Status
32	September 6, 2022	Study Status
33	October 3, 2022	Study Status
34	November 28, 2022	Study Status
35	December 27, 2022	Study Status
36	January 23, 2023	Study Status
37	February 21, 2023	Study Status
38	March 20, 2023	Study Status
39	April 12, 2023	Study Status
40	May 3, 2023	Study Status
41	June 28, 2023	Study Status
42	July 19, 2023	Study Status
43	August 15, 2023	Study Status
44	September 12, 2023	Study Status
45	October 10, 2023	Contacts/Locations and Study Status
46	November 8, 2023	Study Status
47	December 5, 2023	Study Status
48	January 2, 2024	Study Status
49	February 27, 2024	Study Status
50	March 26, 2024	Study Status
51	April 23, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	10008
Brief Title:	Survivorship of Attune Primary Total Knee Prosthesis
Official Title:	Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
Secondary IDs:

Study Status


Record Verification:	May 2020
Overall Status:	Active, not recruiting
Study Start:	February 1, 2013
Primary Completion:	February 1, 2030 [Anticipated]
Study Completion:	February 1, 2030 [Anticipated]

First Submitted:	December 18, 2012
First Submitted that Met QC Criteria:	December 18, 2012
First Posted:	December 21, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	May 18, 2020
Last Update Posted:	May 19, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	DePuy International
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description

Brief 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.

Detailed 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.

Conditions


Conditions:	Noninflammatory Degenerative Joint Disease
Keywords:	Osteoarthritis

Study Design


Study Type:	Observational
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	1542 [Actual]
Number of Groups/Cohorts	1

Groups and Interventions

Groups/Cohorts	Interventions
Attune Primary Total Knee Replacement Subjects will receive one of the following Attune total knee implants: Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)	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).

Outcome Measures


Primary Outcome Measures:
1.	Survivorship of each configuration. [ Time Frame: Minimum 15 years (5414 - 5658 days) ] Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
Secondary Outcome Measures:
1.	Survivorship [ Time Frame: Minimum 5 years (1764 - 3588 days) ] Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
2.	Survivorship [ Time Frame: Minimum 10 years (3589 - 5413 days) ] Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
3.	Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 1 year (304 - 668 days) ] 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.
4.	Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 2 years (669 - 1763 days) ] 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.
5.	Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 5 years (1764 - 3588 days) ] 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.
6.	Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 10 years (3589 - 5413 days) ] 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.
7.	Implant fixation: Radiographic assessment of bone-implant interface performance [ Time Frame: Minimum 15 years (5414 - 5658 days) ] 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.
8.	Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L) [ Time Frame: 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). ] EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
9.	Patient-reported Outcome: Oxford Knee Score [ Time Frame: 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). ] 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.
10.	Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 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). ] 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.
11.	Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP) [ Time Frame: 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). ] 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.
12.	Patient-reported Outcome: Knee Society Score [ Time Frame: 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). ] 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.
13.	Evaluate the impact of surgeon learning curve on clinical and functional outcomes [ Time Frame: <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). ] 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.
14.	Evaluate changes in femoral component and tibial component alignment [ Time Frame: 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). ] 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.
15.	Type and Frequency of Adverse Events (AEs) for all enrolled subjects [ Time Frame: 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). ] All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.

Eligibility


Minimum Age:	22 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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.

Contacts/Locations


Study Officials:	Clarisse Fletcher, MBA, MHA Study Director DePuy Orthopaedics
Locations:	United States, Arizona
	Mayo Clinic Arizona Scottsdale, Arizona, United States, 85259
	United States, California
	Orthopaedic Specialty Institute Orange, California, United States, 92868
	United States, Colorado
	Orthopaedic Center of the Rockies Fort Collins, Colorado, United States, 80525
	United States, Florida
	Florida Research Associates, LLC DeLand, Florida, United States, 32720
	United States, Indiana
	Center for Hip and Knee Surgery Mooresville, Indiana, United States, 46158
	United States, Iowa
	Miller Orthopedic Specialists Council Bluffs, Iowa, United States, 51503
	University of Iowa Hospitals & Clinics Iowa City, Iowa, United States, 52242
	United States, Kentucky
	The Arthroplasty Foundation, Inc. Louisville, Kentucky, United States, 40215
	United States, Maryland
	Anne Arundel Orthopaedic Surgeons Annapolis, Maryland, United States, 21401
	United States, Missouri
	Washington University School of Medicine Saint Louis, Missouri, United States, 63110
	United States, New Hampshire
	New London Hospital New London, New Hampshire, United States, 03257
	United States, Ohio
	Cardinal Orthopaedic Institute Columbus, Ohio, United States, 43213
	OrthoNeuro Westerville, Ohio, United States, 43081
	United States, Pennsylvania
	Penn State Hershey Bone & Joint Institute Hershey, Pennsylvania, United States, 17033
	Abington Orthopaedic Specialists, PC Willow Grove, Pennsylvania, United States, 19090
	United States, Texas
	Texas Institute for Hip and Knee Surgery, LLC Austin, Texas, United States, 78705
	Australia, South Australia
	Canberra Hospital-Trauma & Orthopaedic Research Unit Adelaide, South Australia, Australia, ACT 2600
	Austria, Lower Austria
	Univ.-Klinik für Orthopädie Vienna, Lower Austria, Austria, 1090
	Austria, Upper Austria
	Krankenhaus der Barmherzigen Linz, Upper Austria, Austria, 4010
	Belgium
	Monica Camputs O.L.V. Middelares Antwerp, Belgium, 2100
	Canada, Ontario
	University of Western Ontario-Department of Orthopaedic Surgery London, Ontario, Canada, N6A 5A5
	Germany
	UniversitatsKlinikum Heidelberg Heidelberg, Germany, 69118
	Germany, Bavaria
	Orthopädische Klinik für die Universität Regensburg Bad Abbach, Bavaria, Germany, 3077
	Hong Kong
	Queen Mary Hospital Pokfulam, Hong Kong
	Korea, Republic of
	Seoul National University Hospital Seoul, Korea, Republic of, 110-744
	Korea, Republic of, Gyeonggi-do
	Seoul National Univ Bundang Hospital - Joint Reconstruction Center Seoul, Gyeonggi-do, Korea, Republic of, 463-707
	Malaysia
	University Malaya Medical Centre Kuala Lumpur, Malaysia, 59100
	New Zealand
	Ascot Hospital Auckland, New Zealand
	Singapore
	Singapore General Hospital-Dept of Orthopaedic Surgery Singapore, Singapore, 169608
	Switzerland
	Schulthess Klinik Zurich, Switzerland
	Thailand
	Bhumibol Adulyadej Hospital, The Royal Thai Air Force-Dept of Orthopaedics Bangkok, Thailand, 10220
	United Kingdom
	Princess Alexandria Hospital Harlow, United Kingdom, CM20 1QX
	Guys Hospital London, United Kingdom, SE1 9RT
	Clifton Park NHS Treatment Centre York, United Kingdom, YO30 5RA
	United Kingdom, Fife
	Queen Mary Hospital Dunfermline, Fife, United Kingdom, KY12 OSU
	United Kingdom, Scotland
	New Royal Infirmary of Edinburgh Edinburgh, Scotland, United Kingdom, EH16 4SA

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