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Completed

NCT Number: NCT04079751

Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hospital, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Active or prior infection
  • Medical condition precluding major surgery
  • Inflammatory arthropathy
  • Prior patellectomy
  • PCL deficiency
  • Major Coronal plane deformity
  • Valgus alignment
  • Bone defects requiring augments, cones and/or stemmed implants
  • Body Mass Index 45 or more

Treatment and study plan

Neutral Mechanical Alignment

Procedure

Hip-knee-ankle angle of 180° ± 3°.

Anatomical Alignment

Procedure

Restoring a patient's pre-diseased limb alignment

Primary outcomes

  1. Implant migration

    Time frame: 2 years

    Measured via radiosteriometric analysis (RSA)

Secondary outcomes

  1. Oxford-12 knee score

    Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years

    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.

  2. Pain Catastrophizing Scale (PCS)

    Time frame: Pre-operative, 12 months

    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.

  3. European Quality of Life (EQ-5D-5L)

    Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years

    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.

  4. Pre-operative Patient's Knee Implant Performance (PKIP)

    Time frame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years

    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.

  5. 7. University of California at Los Angeles (UCLA) Activity Level scale

    Time frame: Pre-operative, 6 months, 1 year, 2 years

    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.

  6. Pain VAS

    Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years

    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)

  7. Patient satisfaction: VAS

    Time frame: Preoperative, 3 Months, 6 Months, 1 Year, 2 Years

    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)

  8. Patient complications

    Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years

    Evaluate the type and frequency of the complications/adverse events.

  9. Hospital stay

    Time frame: Up to 1 week

    Number of days in hospital

  10. Tourniquet time

    Time frame: Intraoperative

    Length of time tourniquet was applied (minutes)

  11. Length of surgery

    Time frame: Intraoperative

    Length of surgery, from open to closing of incision (minutes)

  12. Blood loss

    Time frame: Intraoperative

    Amount of blood loss during the procedure (mL)

  13. Anesthesia type

    Time frame: Intraoperative

    Anesthesia methods (general, spinal, epidural, TXA)

  14. Peri-operative pain management

    Time frame: Intraoperative

    A tabulation of the pain management (Peri-Articular Injection, Femoral Nerve Block, Add. Canal Block or none) used during the procedure.

  15. Soft tissue release

    Time frame: Intraoperative

    A tabulation of the tissue released during the procedure (MCL, LCL, PCL, Posterior Capsule Release).

Sponsors and collaborators

Lead sponsor

Canadian Radiostereometric Analysis Network

Other

Registry information

Official study title

Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Anatomic (Femur First) to Neutral Mechanical Alignment Techniques

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2019
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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