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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01754363




Registration number
NCT01754363
Ethics application status
Date submitted
18/12/2012
Date registered
21/12/2012
Date last updated
22/05/2024

Titles & IDs
Public title
Survivorship of Attune Primary Total Knee Prosthesis
Scientific title
Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
Secondary ID [1] 0 0
10008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Noninflammatory Degenerative Joint Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Attune Primary Total Knee Replacement

Experimental: 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)


Treatment: Devices: 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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survivorship of each configuration.
Timepoint [1] 0 0
Minimum 15 years (5414 - 5658 days)
Secondary outcome [1] 0 0
Survivorship
Timepoint [1] 0 0
Minimum 5 years (1764 - 3588 days)
Secondary outcome [2] 0 0
Survivorship
Timepoint [2] 0 0
Minimum 10 years (3589 - 5413 days)
Secondary outcome [3] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [3] 0 0
Minimum 1 year (304 - 668 days)
Secondary outcome [4] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [4] 0 0
Minimum 2 years (669 - 1763 days)
Secondary outcome [5] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [5] 0 0
Minimum 5 years (1764 - 3588 days)
Secondary outcome [6] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [6] 0 0
Minimum 10 years (3589 - 5413 days)
Secondary outcome [7] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [7] 0 0
Minimum 15 years (5414 - 5658 days)
Secondary outcome [8] 0 0
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
Timepoint [8] 0 0
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 outcome [9] 0 0
Patient-reported Outcome: Oxford Knee Score
Timepoint [9] 0 0
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 outcome [10] 0 0
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [10] 0 0
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 outcome [11] 0 0
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
Timepoint [11] 0 0
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 outcome [12] 0 0
Patient-reported Outcome: Knee Society Score
Timepoint [12] 0 0
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 outcome [13] 0 0
Evaluate the impact of surgeon learning curve on clinical and functional outcomes
Timepoint [13] 0 0
<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 outcome [14] 0 0
Evaluate changes in femoral component and tibial component alignment
Timepoint [14] 0 0
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 outcome [15] 0 0
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
Timepoint [15] 0 0
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).

Eligibility
Key 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.
Minimum age
22 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
Accrual to date
Final
1542
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Canberra Hospital-Trauma & Orthopaedic Research Unit - Adelaide
Recruitment postcode(s) [1] 0 0
ACT 2600 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Austria
State/province [11] 0 0
Lower Austria
Country [12] 0 0
Austria
State/province [12] 0 0
Upper Austria
Country [13] 0 0
Belgium
State/province [13] 0 0
Antwerp
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Germany
State/province [15] 0 0
Bavaria
Country [16] 0 0
Germany
State/province [16] 0 0
Heidelberg
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Dongjak-gu
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
New Zealand
State/province [21] 0 0
Auckland
Country [22] 0 0
Singapore
State/province [22] 0 0
Singapore
Country [23] 0 0
Switzerland
State/province [23] 0 0
Zurich
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Fife
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Scotland
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Harlow
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London
Country [28] 0 0
United Kingdom
State/province [28] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DePuy International
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01754363
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Allyson Morris
Address 0 0
DePuy Synthes
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries