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Survivorship of Attune Primary Total Knee Prosthesis

Primary Purpose

Noninflammatory Degenerative Joint Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Attune Primary Total Knee Replacement
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Noninflammatory Degenerative Joint Disease focused on measuring Osteoarthritis

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Arizona
  • Orthopaedic Specialty Institute
  • Orthopaedic Center of the Rockies
  • Florida Research Associates, LLC
  • Center for Hip and Knee Surgery
  • University of Iowa Hospitals & Clinics
  • Washington University School of Medicine
  • Orthopedic One
  • OrthoNeuro
  • Penn State Hershey Bone & Joint Institute
  • Abington Orthopaedic Specialists, PC
  • Texas Institute for Hip and Knee Surgery, LLC
  • Canberra Hospital-Trauma & Orthopaedic Research Unit
  • Univ.-Klinik für Orthopädie
  • Krankenhaus der Barmherzigen
  • Monica Camputs O.L.V. Middelares
  • University of Western Ontario-Department of Orthopaedic Surgery
  • Orthopädische Klinik für die Universität Regensburg
  • UniversitatsKlinikum Heidelberg
  • Queen Mary Hospital
  • Seoul National University Boramae Hospital
  • Seoul National University Hospital
  • University Malaya Medical Centre
  • Ascot Hospital
  • Singapore General Hospital-Dept of Orthopaedic Surgery
  • Schulthess Klinik
  • Queen Mary Hospital
  • New Royal Infirmary of Edinburgh
  • Princess Alexandria Hospital
  • Guys Hospital
  • Clifton Park NHS Treatment Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Attune Primary Total Knee Replacement

Arm Description

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Survivorship
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
Survivorship
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 18, 2012
Last Updated
October 10, 2023
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT01754363
Brief Title
Survivorship of Attune Primary Total Knee Prosthesis
Official Title
Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
February 1, 2030 (Anticipated)
Study Completion Date
February 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noninflammatory Degenerative Joint Disease
Keywords
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1542 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allyson Morris
Organizational Affiliation
DePuy Synthes
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Orthopaedic Specialty Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Orthopaedic Center of the Rockies
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Florida Research Associates, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Center for Hip and Knee Surgery
City
Mooresville
State/Province
Indiana
ZIP/Postal Code
46158
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Orthopedic One
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
OrthoNeuro
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
Penn State Hershey Bone & Joint Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Abington Orthopaedic Specialists, PC
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Texas Institute for Hip and Knee Surgery, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Canberra Hospital-Trauma & Orthopaedic Research Unit
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
ACT 2600
Country
Australia
Facility Name
Univ.-Klinik für Orthopädie
City
Vienna
State/Province
Lower Austria
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus der Barmherzigen
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4010
Country
Austria
Facility Name
Monica Camputs O.L.V. Middelares
City
Antwerp
ZIP/Postal Code
2100
Country
Belgium
Facility Name
University of Western Ontario-Department of Orthopaedic Surgery
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Orthopädische Klinik für die Universität Regensburg
City
Bad Abbach
State/Province
Bavaria
ZIP/Postal Code
3077
Country
Germany
Facility Name
UniversitatsKlinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69118
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Seoul National University Boramae Hospital
City
Seoul
State/Province
Dongjak-gu
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-714
Country
Korea, Republic of
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Ascot Hospital
City
Auckland
Country
New Zealand
Facility Name
Singapore General Hospital-Dept of Orthopaedic Surgery
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Schulthess Klinik
City
Zurich
Country
Switzerland
Facility Name
Queen Mary Hospital
City
Dunfermline
State/Province
Fife
ZIP/Postal Code
KY12 OSU
Country
United Kingdom
Facility Name
New Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Princess Alexandria Hospital
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Clifton Park NHS Treatment Centre
City
York
ZIP/Postal Code
YO30 5RA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Survivorship of Attune Primary Total Knee Prosthesis

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