Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not

Gait Analysis, Stair Performance and CT-based Micromotion Analysis in Robotic Assisted Total Knee Arthroplasty Comparing Bi-cruciate Retaining vs Cruciate Retaining Implants: A Single Centre Patient-blinded Randomized Controlled Trial

The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.

The main questions it aims to answer are:

Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform

• Gait analysis
• Stair performance test
• CT based Micromotion analysis of the implant micromovement

Study Overview

• Status: Not yet recruiting
• Conditions: Arthroplasty; Arthritis Knee; Gait Analysis
• Intervention / Treatment: Device: Journey II CR; Device: Journey II XR

Detailed Description

A randomized controlled clinical trial intended to compare walking function and movement of the prosthesis after robot-assisted knee replacement surgery with two knee replacement designs; One prosthesis is preserving the anterior cruciate ligament (Smith+Nephew Journey II XR) and the other is sacrificing the anterior cruciate ligament (Smith+Nephew Jourrney II CR).

It is common to remove anterior cruciate ligament during knee replacement surgery. There is speculation about this weakens the balance in the operated knee and whether this can explain some of the problems that up to 20% experience after knee replacement surgery.

Preservation of the anterior cruciate ligament during knee replacement surgery may provide a more natural movement and better balance in the operated knee, and this in turn could provide increased patient satisfaction.

Previous studies have shown that knee replacement surgery where the anterior cruciate ligament is preserved has an increased incidence of per- and postoperative complications and reduced implant survival. Robot assisted navigation in knee arthroplasty surgery has shown the possibility of increased precision and accuracy when implanting the knee prostheses, and therefore might provide increased satisfaction when performing elective knee prosthetic surgery with robotic assistance and at the same time preserving the anterior cruciate ligament without an increased risk of complications.

In this study, postoperative function is assessed by looking at whether the walking pattern has normalized.

Gait analyses with comparison of the two groups is carried out both before surgery and 2, 6 and 12 months after surgery.

Primary endpoint is self-selected walking speed at 12 months follow-up. Secondary endpoints include other gait analysis parameters, result of stair test, as well as patient-reported pain, satisfaction and function (NRS, EQ-5D-5L, KOOS-PS, IKSS, FJS-12), knee mobility, stability, and hip-knee-ankle angle.

Complications related to the surgery or the course afterwards is noted. The study will also compare the movement of the prosthetic components in relation to the skeleton over a period of 2 years using a CT based micro motion analysis method (CT-RSA) making it possible to assess implant migration over time.

Increased movement can predict early loosening of the prosthesis.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Sjøstrøm, MD; Phone Number: +4772575241; Email: anders.sjostrom@stolav.no
• Study Contact Backup: Name: Tina Strømdal-Wik, MD, PhD; Phone Number: +4772826521; Email: Tina.stromdal.Wik@stolav.no

Study Locations

• Norway
  • Trøndelag
    • Trondheim, Trøndelag, Norway, 7006
      • St.Olavs Hospital
      • Contact: Anders Sjøstrøm, MD; Phone Number: +4772575241; Email: anders.sjostrom@stolav.no
      • Sub-Investigator: Siri Bjørgen Winther, PhD
      • Sub-Investigator: Sølvi Liabekk Selli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Severe osteoarthritis Ahlbäck grade 3 or 4 affecting 2-3 compartments
• Ability to preoperatively walk 30 m independently without support before surgery
• Ability to give written consent.
• CPAK (Coronal Plane alignment of the Knee) I, II or III

Exclusion Criteria:

• Previous cruciate ligament surgery in affected knee
• Previous osteotomy in affected knee,
• Posttraumatic arthritis in affected knee
• History of infectious arthritis
• Rheumatoid arthritis
• Significant preoperative varus or valgus deformity >15º
• Evidence of damaged Anterior Cruciate Ligament and/or Posterior Cruciate Ligament
• Flexion contracture > 10 º, - Planning reveals the need for a complex implant ( stem, augment or higher level of constraint).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Journey II CR; Implantation of Journey II CR sacrificing the anterior cruciate ligament.	Device: Journey II CR; Implantation of Journey II CR Crucite Retaining Knee
Active Comparator: Journey II XR; Implantation of Journey II XR retaining the anterior cruciate ligament.	Device: Journey II XR; Implantation of Journey II XR Bi Cruciate Retaining Knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferred walking speed (meter/minute) after surgery	Evaluation of gait with preferred walking speed (meter/minute) measured on a electronic walkway system	twelve months after surgery.
CT-RSA measured maximum total point of motion(MTPM)	CT-RSA measured maximum total point og motion(MTPM)in millimeters and rotation of the implant in degrees compared to baseline value	6,12 and 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of max walking speed(m/minute)	Assesment of maximum walking speed(meter/minute) measured on a electronic walkway system	twelve months after surgery.
stride length(cm)	Assesment of stride length (centimeters) measured on a electronic walkway system	twelve months after surgery.
step length in mid stance phase (cm)	Assesment of step length(centimeters) in mid stance phase measured on a electronic walkway system	twelve months after surgery.
single leg support time(s)	Assesment of single leg support time(seconds) measured on a electronic walkway system	twelve months after surgery.
double-leg support time(s)	Assesment of double leg support time (seconds) measured on a electronic walkway system	twelve months after surgery.
stair performance(s)	A 11-step stair ascend/descend test (STTotal-11) measures the time(seconds) it takes a subject to ascend and descend a flight of 11 steps (each step 17 cm high and 30 cm deep).	twelve months after surgery.
Clinical evaluation of range of motion .	Measure how much the knee will bend and extend in degrees both passive and active. Measure the Anterio-Posterior and Medio-Lateral stability i millimeters	twelve months after surgery.
Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L),	EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area (i.e. I have no problems walking about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.	twelve months after surgery.
IKSS (International Knee Society System knee and function score)	Knee Society Clinical Rating System (KSS) provides a objective scoring system to rate the knee and patient's functional abilities before and after total knee arthroplasty. It has a Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee condition	twelve months after surgery.
FJS-12 (Forgotten Joint score)	Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities	twelve months after surgery.
Clinical evaluation of Anteroposterior stability.	The anterior-posterior (AP) stability of the knee is an important aspect of functional performance and is measured in millimeters	twelve months after surgery.
Clinical evaluation of Mediolateral stability.	Mediolateral stability is measured in degrees and evaluated in 3 groups (Group 1: <5°, Group 2: 6°-9°, Group 3: ≥10°	twelve months after surgery.
Rating pain using NRS (Numeric Rating Scale).	NRS is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable	twelve months after surgery.
KOOS-PS (Knee Injury and Osteoarthritis Outcome score)	The KOOS-PS is a derivative of the Knee Injury and Osteoarthritis Score (KOOS). The KOOS-PS tool is intended to attain a feasible, short measure of physical function with interval level properties to assess the patient's opinion about their knee and associated problems. It measures Function (rising from sitting, bending to floor, putting on socks/stockings, rising from bed) and Sports (squatting, kneeling, twisting/pivoting) subscales. Items are scored from 0 to 4 and summed to give a raw score from 0 to 28, with lower scores representing higher levels of functional status.	twelve months after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
A long leg X-Ray identifying outliers with Hip Knee Ankle angle Varus <-3 ºor Valgus >3 º	Examination of long leg radiographs measuring the Hip-Knee Ankle angle in degrees	8 weeks
Presence of eminence fractures	Examination of postoperative radiographs evaluating the presence of eminence fractures	2 days postoperatively

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Smith & Nephew, Inc.
• Investigators: Study Director: Tina Strømdal-Wik, MD, PhD, <St Olav- NTNU?

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 427976

Drug and device information, study documents

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