Osteo Arthritis KneeNCT04334304
Evaluation of Standard and Robot Assisted Total Knee Arthroplasty with a Bicrucatie Retaining Prosthesis
A study testing Total Knee Prosthesis - type Bicruciate retaining, Robot-assisted Total Knee Arthroplasty and Total Knee Prosthesis - type Posterior Stabilized in people with Osteo Arthritis Knee, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Total Knee Prosthesis - type Bicruciate retaining, Robot-assisted Total Knee Arthroplasty and Total Knee Prosthesis - type Posterior Stabilized
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 11 Nov 2024
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- End stage osteoarthritis of the knee joint with failed conservative treatment
Who cannot join
- Previous ligament trauma
- Previous fracture of femur or tibia
- Fixed flexion contracture > 10°
- Flexion < 110°
- Coronal deformity > 15°
- Previous infection of the knee joint
- Ligament insufficiency
- Neurologic conditions
Trial locations and contacts
1 site in 1 country.
About this study
The first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Total Knee Prosthesis - type Bicruciate retaining, Robot-assisted Total Knee Arthroplasty, Total Knee Prosthesis - type Posterior Stabilized
- Keywords
- Total Knee Arthroplasty, Robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Prosthesis - type Bicruciate retainingProcedure or surgery
A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).
Robot-assisted Total Knee ArthroplastyProcedure or surgery
A total knee arthroplasty will be performed with robot-assistance (NAVIO).
Total Knee Prosthesis - type Posterior StabilizedProcedure or surgery
A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).
| Study group | Role | What they receive |
|---|---|---|
| Posterior Stabilized TKA without robot-assistance | Active comparator | A TKA procedure will carried out: Posterior Stabilized TKA without robot-assistance Receives: Procedure: Total Knee Prosthesis - type Posterior Stabilized |
| Posterior Stabilized with robot-assistance | Experimental | A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance Receives: Procedure: Robot-assisted Total Knee Arthroplasty; Procedure: Total Knee Prosthesis - type Posterior Stabilized |
| Bicruciate retaining TKA without robot-assistance | Experimental | A TKA procedure will carried out: Bicruciate retaining TKA without robot-assistance Receives: Procedure: Total Knee Prosthesis - type Bicruciate retaining |
| Bicruciate retaining TKA with robot-assistance | Experimental | A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance Receives: Procedure: Total Knee Prosthesis - type Bicruciate retaining; Procedure: Robot-assisted Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Preoperative
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Preoperative
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Preoperative
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 52 representing extreme problems.
Measured: Preoperative
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 100 representing extreme problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary outcomes (4)
Alignment
Coronal alignment on xrays. The lateral distal femoral angle (LDFA) will be evaluated. This is the angle between the mechanical femoral axis and the line between the distal articular surface of the femur. Additionally the medial proximal tibial angle (MPTA) will be evaluated. This is the line between the condylar surface and the mechanical axis of the tibia on a coronal radiograph.
Measured: Preoperative and postoperatively at 6 weeks and 6 months.
Knee laxity
Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph.
Measured: Preoperative and postoperatively at 1 year.
Knee laxity
Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an AP laxitymeter (GENOUROB; CE Marked). With a standardized setup, anteroposterior laxity can be obtained by measuring the anteroposterior deviation from the neutral position with up to 300N of force.
Measured: Preoperative and postoperatively at 1 year.
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
Knee kinematics in 3D obtained with fluoroscopy. Patients will be asked to perform squats, a flexion/extension movement, ascend and descend stairs. 3D motion of the prosthesis components can be obtained by projecting the 3D file of the prosthesis components onto the fluoroscopy images.
Measured: Postoperatively at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Jan 2020
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Why it stopped: Patient inclusion difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Model description
- Arm 1: Posterior Stabilized TKA without robot Arm 2: Posterior Stabilized TKA with robot Arm 3: Bicruciate retaining TKA without robot Arm 4: Bicruciate retaining TKA with robot
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Victor, PhD, Study chair, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334304
- Sponsor's protocol ID
- 2018/1281 (BC-3831)
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Standard and Robot Assisted Total Knee Arthroplasty with a Bicrucatie Retaining Prosthesis
- ClinicalTrials.gov ID
- NCT04334304
- Acronym / sponsor ID
- 2018/1281 (BC-3831)
- Conditions
- Osteo Arthritis Knee
- Keywords
- Total Knee Arthroplasty, Robot
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient inclusion difficult.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 6 Apr 2020 (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 first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Arm 1: Posterior Stabilized TKA without robot Arm 2: Posterior Stabilized TKA with robot Arm 3: Bicruciate retaining TKA without robot Arm 4: Bicruciate retaining TKA with robot
| Arm | Type | Receives |
|---|---|---|
| Posterior Stabilized TKA without robot-assistance | Active comparator | Procedure: Total Knee Prosthesis - type Posterior StabilizedA TKA procedure will carried out: Posterior Stabilized TKA without robot-assistance |
| Posterior Stabilized with robot-assistance | Experimental | Procedure: Robot-assisted Total Knee Arthroplasty, Procedure: Total Knee Prosthesis - type Posterior StabilizedA TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance |
| Bicruciate retaining TKA without robot-assistance | Experimental | Procedure: Total Knee Prosthesis - type Bicruciate retainingA TKA procedure will carried out: Bicruciate retaining TKA without robot-assistance |
| Bicruciate retaining TKA with robot-assistance | Experimental | Procedure: Total Knee Prosthesis - type Bicruciate retaining, Procedure: Robot-assisted Total Knee ArthroplastyA TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- End stage osteoarthritis of the knee joint with failed conservative treatment
Key exclusion criteria (8 listed)
- Previous ligament trauma
- Previous fracture of femur or tibia
- Fixed flexion contracture > 10°
- Flexion < 110°
- Coronal deformity > 15°
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 |
|---|---|---|
| Total Knee Prosthesis - type Bicruciate retainingA total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS). | Procedure or surgery | Bicruciate retaining TKA with robot-assistance, Bicruciate retaining TKA without robot-assistance |
| Robot-assisted Total Knee ArthroplastyA total knee arthroplasty will be performed with robot-assistance (NAVIO). | Procedure or surgery | Bicruciate retaining TKA with robot-assistance, Posterior Stabilized with robot-assistance |
| Total Knee Prosthesis - type Posterior StabilizedA total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS). | Procedure or surgery | Posterior Stabilized TKA without robot-assistance, Posterior Stabilized with robot-assistance |
Primary outcome
Patient reported outcome measures
Time frame: Preoperative
The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Patient reported outcome measures
Time frame: Preoperative
The following patient reported outcome measures will be evaluated: Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Patient reported outcome measures
Time frame: Preoperative
The following patient reported outcome measures will be evaluated: EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Patient reported outcome measures
Time frame: Preoperative
The following patient reported outcome measures will be evaluated: Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 52 representing extreme problems.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 100 representing extreme problems.
4 secondary outcomes
Alignment
Time frame: Preoperative and postoperatively at 6 weeks and 6 months.
Knee laxity
Time frame: Preoperative and postoperatively at 1 year.
Knee laxity
Time frame: Preoperative and postoperatively at 1 year.
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
Time frame: Postoperatively at 1 year.
Results and safety
The study was stopped early (reason given: Patient inclusion difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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.
Jan Victor, PhD study chair
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Prosthesis - type Bicruciate retaining, Robot-assisted Total Knee Arthroplasty and Total Knee Prosthesis - type Posterior Stabilized in people with Osteo Arthritis Knee, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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: stopped early, as of the sponsor's last update on 9 Dec 2024. 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 Belgium. 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 stopped early (reason given: Patient inclusion difficult.). Results are not available in the source record.
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?
Patient reported outcome measures (time frame: Preoperative). The study lists 9 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 9 Dec 2024.