Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Neutral Mechanical Alignment; Procedure: Anatomical Alignment

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:

1. Neutral mechanical alignment;
2. 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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 3S8
      • Concordia Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
2. Varus knee deformity of 0 to 10 degrees
3. Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
4. Between the ages of 21 and 80 inclusive
5. Patients willing and able to comply with follow-up requirements and self-evaluations
6. Ability to give informed consent

Exclusion Criteria:

1. Active or prior infection
2. Medical condition precluding major surgery
3. Inflammatory arthropathy
4. Prior patellectomy
5. PCL deficiency
6. Major Coronal plane deformity
7. Valgus alignment
8. Bone defects requiring augments, cones and/or stemmed implants
9. Body Mass Index 45 or more

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neutral Mechanical Alignment; Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment	Procedure: Neutral Mechanical Alignment; Hip-knee-ankle angle of 180° ± 3°.
Active Comparator: Anatomical Alignment; Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment	Procedure: Anatomical Alignment; Restoring a patient's pre-diseased limb alignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant migration	Measured via radiosteriometric analysis (RSA)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Number of days in hospital	Up to 1 week
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.	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.	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.	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.	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.	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)	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)	Preoperative, 3 Months, 6 Months, 1 Year, 2 Years
Patient complications	Evaluate the type and frequency of the complications/adverse events.	Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years
Tourniquet time	Length of time tourniquet was applied (minutes)	Intraoperative
Length of surgery	Length of surgery, from open to closing of incision (minutes)	Intraoperative
Blood loss	Amount of blood loss during the procedure (mL)	Intraoperative
Anesthesia type	Anesthesia methods (general, spinal, epidural, TXA)	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.	Intraoperative
Soft tissue release	A tabulation of the tissue released during the procedure (MCL, LCL, PCL, Posterior Capsule Release).	Intraoperative

Collaborators and Investigators

• Sponsor: Canadian Radiostereometric Analysis Network
• Investigators: Principal Investigator: Thomas Turgeon, Concordia Joint Replacement Group

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: B2018-139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes