Arthritis KneeNCT06264999
Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not
A study testing Journey II CR and Journey II XR in people with Arthritis Knee and Arthroplasty, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis Knee, Arthroplasty, Gait Analysis
- What is being tested?
- Journey II CR and Journey II XR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2025to Apr 2026
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Arthritis Knee, Arthroplasty, Gait Analysis
- Being tested
- Journey II CR, Journey II XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Journey II CRDevice
Implantation of Journey II CR Crucite Retaining Knee
Journey II XRDevice
Implantation of Journey II XR Bi Cruciate Retaining Knee
| Study group | Role | What they receive |
|---|---|---|
| Journey II CR | Active comparator | Implantation of Journey II CR sacrificing the anterior cruciate ligament. Receives: Device: Journey II CR |
| Journey II XR | Active comparator | Implantation of Journey II XR retaining the anterior cruciate ligament. Receives: Device: Journey II XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred walking speed (meter/minute) after surgery
Evaluation of gait with preferred walking speed (meter/minute) measured on a electronic walkway system
Measured: 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
Measured: 6,12 and 24 months after surgery
Secondary outcomes (14)
evaluation of max walking speed(m/minute)
Assesment of maximum walking speed(meter/minute) measured on a electronic walkway system
Measured: twelve months after surgery.
stride length(cm)
Assesment of stride length (centimeters) measured on a electronic walkway system
Measured: 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
Measured: twelve months after surgery.
single leg support time(s)
Assesment of single leg support time(seconds) measured on a electronic walkway system
Measured: twelve months after surgery.
double-leg support time(s)
Assesment of double leg support time (seconds) measured on a electronic walkway system
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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°
Measured: twelve months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: Due to implant-related factors, forced to terminate the planned study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor
- Investigators
- Tina Strømdal-Wik, MD, PhD, Study director, <St Olav- NTNU?
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264999
- Sponsor's protocol ID
- 427976
- Status last verified
- Jun 2025
- First submitted
- 28 Dec 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06264999
- Acronym / sponsor ID
- 427976
- Conditions
- Arthritis Knee, Arthroplasty, Gait Analysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to implant-related factors, forced to terminate the planned study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 20 Feb 2024 (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 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Journey II CR | Active comparator | Device: Journey II CRImplantation of Journey II CR sacrificing the anterior cruciate ligament. |
| Journey II XR | Active comparator | Device: Journey II XRImplantation of Journey II XR retaining the anterior cruciate ligament. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Previous cruciate ligament surgery in affected knee
- Previous osteotomy in affected knee,
- Posttraumatic arthritis in affected knee
- History of infectious arthritis
- Rheumatoid arthritis
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 |
|---|---|---|
| Journey II CRImplantation of Journey II CR Crucite Retaining Knee | Device | Journey II CR |
| Journey II XRImplantation of Journey II XR Bi Cruciate Retaining Knee | Device | Journey II XR |
Primary outcome
Preferred walking speed (meter/minute) after surgery
Time frame: twelve months after surgery.
Evaluation of gait with preferred walking speed (meter/minute) measured on a electronic walkway system
CT-RSA measured maximum total point of motion(MTPM)
Time frame: 6,12 and 24 months after surgery
CT-RSA measured maximum total point og motion(MTPM)in millimeters and rotation of the implant in degrees compared to baseline value
14 secondary outcomes
evaluation of max walking speed(m/minute)
Time frame: twelve months after surgery.
stride length(cm)
Time frame: twelve months after surgery.
step length in mid stance phase (cm)
Time frame: twelve months after surgery.
single leg support time(s)
Time frame: twelve months after surgery.
double-leg support time(s)
Time frame: twelve months after surgery.
stair performance(s)
Time frame: twelve months after surgery.
Rating pain using NRS (Numeric Rating Scale).
Time frame: twelve months after surgery.
KOOS-PS (Knee Injury and Osteoarthritis Outcome score)
Time frame: twelve months after surgery.
Clinical evaluation of range of motion .
Time frame: twelve months after surgery.
Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L),
Time frame: twelve months after surgery.
IKSS (International Knee Society System knee and function score)
Time frame: twelve months after surgery.
FJS-12 (Forgotten Joint score)
Time frame: twelve months after surgery.
Clinical evaluation of Anteroposterior stability.
Time frame: twelve months after surgery.
Clinical evaluation of Mediolateral stability.
Time frame: twelve months after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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.
Tina Strømdal-Wik, MD, PhD study director
<St Olav- NTNU?
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Journey II CR and Journey II XR in people with Arthritis Knee and Arthroplasty, run by St. Olavs Hospital at 1 site in Norway.
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 8 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: withdrawn, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 was withdrawn before enrolling participants, so there are no results.
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?
Preferred walking speed (meter/minute) after surgery (time frame: twelve months after surgery.). The study lists 2 primary outcomes in all. 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 24 Jun 2025.