Knee OsteoarthritisNCT04079751
Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System
A study testing Neutral Mechanical Alignment and Anatomical Alignment in people with Knee Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 2 sites in Canada.
Trial summary
The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system 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?
- Neutral Mechanical Alignment and Anatomical Alignment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesCanada
- Study dates
- 5 May 2019to 1 Feb 2022
- 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
- Varus knee deformity of 0 to 10 degrees
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- 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
- Inflammatory arthropathy
- Prior patellectomy
- PCL deficiency
- Major Coronal plane deformity
Show all 9Show fewer
- Valgus alignment
- Bone defects requiring augments, cones and/or stemmed implants
- Body Mass Index 45 or more
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 Anatomic (Femur First) to Neutral Mechanical Alignment Techniques
The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.
Read the detailed description
This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two study groups:
- Neutral mechanical alignment;
- Anatomical alignment.
The principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system 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, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery.
- Conditions
- Knee Osteoarthritis
- Being tested
- Neutral Mechanical Alignment, Anatomical Alignment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral Mechanical AlignmentProcedure or surgery
Hip-knee-ankle angle of 180° ± 3°.
Anatomical AlignmentProcedure or surgery
Restoring a patient's pre-diseased limb alignment
| Study group | Role | What they receive |
|---|---|---|
| Neutral Mechanical Alignment | Active comparator | Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment Receives: Procedure: Neutral Mechanical Alignment |
| Anatomical Alignment | Active comparator | Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment Receives: Procedure: Anatomical Alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant migration
Measured via radiosteriometric analysis (RSA)
Measured: 2 years
Secondary outcomes (15)
Oxford-12 knee score
The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like 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.
Measured: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 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: Pre-operative, 12 months
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 generic health status - completed by the subject. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none(0), slight(1), moderate(2), severe(3) or unable to perform(5). Levels are coded 1-5 and an index score is then generated.
Measured: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
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: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
7. 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: Pre-operative, 6 months, 1 year, 2 years
Pain VAS
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, 2 Years
Patient satisfaction: VAS
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, 3 Months, 6 Months, 1 Year, 2 Years
Patient complications
Evaluate the type and frequency of the complications/adverse events.
Measured: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years
Hospital stay
Number of days in hospital
Measured: Up to 1 week
Tourniquet time
Length of time tourniquet was applied (minutes)
Measured: Intraoperative
Length of surgery
Length of surgery, from open to closing of incision (minutes)
Measured: Intraoperative
Blood loss
Amount of blood loss during the procedure (mL)
Measured: Intraoperative
Anesthesia type
Anesthesia methods (general, spinal, epidural, TXA)
Measured: Intraoperative
Peri-operative pain management
A tabulation of the pain management (Peri-Articular Injection, Femoral Nerve Block, Add. Canal Block or none) used during the procedure.
Measured: Intraoperative
Soft tissue release
A tabulation of the tissue released during the procedure (MCL, LCL, PCL, Posterior Capsule Release).
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start5 May 2019
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
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
- Model description
- Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, Principal investigator, Concordia Joint Replacement Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079751
- Sponsor's protocol ID
- B2018-139
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2019
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. 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 Anatomic (Femur First) to Neutral Mechanical Alignment Techniques
- ClinicalTrials.gov ID
- NCT04079751
- Acronym / sponsor ID
- B2018-139
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 6 Sep 2019 (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 purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.
Detailed description
This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two study groups:
- Neutral mechanical alignment;
- Anatomical alignment.
The principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system 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, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.
| Arm | Type | Receives |
|---|---|---|
| Neutral Mechanical Alignment | Active comparator | Procedure: Neutral Mechanical AlignmentTotal knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment |
| Anatomical Alignment | Active comparator | Procedure: Anatomical AlignmentTotal knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Varus knee deformity of 0 to 10 degrees
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
Key exclusion criteria (9 listed)
- Active or prior infection
- Medical condition precluding major surgery
- Inflammatory arthropathy
- Prior patellectomy
- PCL deficiency
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 |
|---|---|---|
| Neutral Mechanical AlignmentHip-knee-ankle angle of 180° ± 3°. | Procedure or surgery | Neutral Mechanical Alignment |
| Anatomical AlignmentRestoring a patient's pre-diseased limb alignment | Procedure or surgery | Anatomical Alignment |
Primary outcome
Implant migration
Time frame: 2 years
Measured via radiosteriometric analysis (RSA)
15 secondary outcomes
Oxford-12 knee score
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pain Catastrophizing Scale (PCS)
Time frame: Pre-operative, 12 months
European Quality of Life (EQ-5D-5L)
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pre-operative Patient's Knee Implant Performance (PKIP)
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
7. University of California at Los Angeles (UCLA) Activity Level scale
Time frame: Pre-operative, 6 months, 1 year, 2 years
Pain VAS
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years
Patient satisfaction: VAS
Time frame: Preoperative, 3 Months, 6 Months, 1 Year, 2 Years
Patient complications
Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years
Hospital stay
Time frame: Up to 1 week
Tourniquet time
Time frame: Intraoperative
Length of surgery
Time frame: Intraoperative
Blood loss
Time frame: Intraoperative
Anesthesia type
Time frame: Intraoperative
Peri-operative pain management
Time frame: Intraoperative
Soft tissue release
Time frame: Intraoperative
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 4 Dec 2025.
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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 principal investigator
Concordia Joint Replacement Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral Mechanical Alignment and Anatomical Alignment 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 6 inclusion and 9 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 4 Dec 2025. 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?
Implant 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 4 Dec 2025.