Knee OsteoarthritisNCT03554720
RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs
A study testing ATTUNE PS Knee and ATTUNE S+ PS Knee in people with Knee Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 2 sites in Canada.
Trial summary
The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ATTUNE PS Knee and ATTUNE S+ PS Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Jul 2018to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Who cannot join
- Active or prior infection
- Medical condition precluding major surgery
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
Concordia Hospital
Winnipeg, Manitoba, R2K 3S8
About this study
Official title: Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs
The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.
Read the detailed description
This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.
- Conditions
- Knee Osteoarthritis
- Being tested
- ATTUNE PS Knee, ATTUNE S+ PS Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTUNE PS KneeDevice
The ATTUNE PS Knee is the standard implants.
ATTUNE S+ PS KneeDevice
The ATTUNE S+ PS Knee is the enhanced fixation.
| Study group | Role | What they receive |
|---|---|---|
| Standard implants | Active comparator | ATTUNE PS Knee Receives: Device: ATTUNE PS Knee |
| Enhanced-Fixation | Active comparator | ATTUNE S+ PS Knee Receives: Device: ATTUNE S+ PS Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSA Migration
Migration of the tibial and femoral components between the 2 device designs.
Measured: 2 Years
Secondary outcomes (9)
Knee Replacement Expectation Survey (KRES)
The KRES is a patient reported questionnaire that consists of 19 questions. The questions ask how each expectation is important in the treatment of the knee. The scale is rated: 1 (Very important) to 5 (This does not apply to me). The score ranges from 19 to 95 with higher scores associated with higher expectations.
Measured: Preoperative
European Quality of Life (EQ-5D-5L)
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments. The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Pain score
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Patient satisfaction
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)
Measured: Preoperative, 6 Months, 1 Year and 2 Years
Oxford 12 Knee
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale
Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.
Measured: Preoperative, 6 Months, 1 Year and 2 Years]
Pain Catastrophizing Scale (PCS)
The patient are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain. Each PCS item is rated on a 5-point scale: 0 (not at all) to 4 (all the time). The PCS total score is computed by summing responses to the 13 items. PCS total scores range from 0 - 52.
Measured: Preoperative and 1 Year
Pre-operative Patient's Knee Implant Performance (PKIP)
The Pre-surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient reported questionnaire that consists of 24 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 Likaert- like response option.
Measured: Preoperative, 6 Months, 1 Year and 2 Years
Patient complications
Evaluate the type and frequency of the complications/adverse events.
Measured: Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start4 Jul 2018
- Primary completion3 Nov 2021
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Innovation Centre, Dalhousie University, London Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD MPH FRCSC, Principal investigator, University of ManitobaGlen Richardson, MD MSc FRCSC, Principal investigator, Dalhousie UniversityDouglas Naudie, MD FRCSC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554720
- Sponsor's protocol ID
- HS21601
- Status last verified
- Jan 2024
- First submitted
- 18 May 2018
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs
- ClinicalTrials.gov ID
- NCT03554720
- Acronym / sponsor ID
- HS21601
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Collaborators
- Orthopaedic Innovation Centre, Dalhousie University, London Health Sciences Centre
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.
Detailed description
This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard implants | Active comparator | Device: ATTUNE PS KneeATTUNE PS Knee |
| Enhanced-Fixation | Active comparator | Device: ATTUNE S+ PS KneeATTUNE S+ PS Knee |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Key exclusion criteria (2 listed)
- Active or prior infection
- Medical condition precluding major surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATTUNE PS KneeThe ATTUNE PS Knee is the standard implants. | Device | Standard implants |
| ATTUNE S+ PS KneeThe ATTUNE S+ PS Knee is the enhanced fixation. | Device | Enhanced-Fixation |
Primary outcome
RSA Migration
Time frame: 2 Years
Migration of the tibial and femoral components between the 2 device designs.
9 secondary outcomes
Knee Replacement Expectation Survey (KRES)
Time frame: Preoperative
European Quality of Life (EQ-5D-5L)
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Pain score
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Patient satisfaction
Time frame: Preoperative, 6 Months, 1 Year and 2 Years
Oxford 12 Knee
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale
Time frame: Preoperative, 6 Months, 1 Year and 2 Years]
Pain Catastrophizing Scale (PCS)
Time frame: Preoperative and 1 Year
Pre-operative Patient's Knee Implant Performance (PKIP)
Time frame: Preoperative, 6 Months, 1 Year and 2 Years
Patient complications
Time frame: Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Turgeon, MD MPH FRCSC principal investigator
University of Manitoba
Glen Richardson, MD MSc FRCSC principal investigator
Dalhousie University
Douglas Naudie, MD FRCSC principal investigator
London Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTUNE PS Knee and ATTUNE S+ PS Knee in people with Knee Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSA Migration (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.