Knee OsteoarthritisNCT05842538
Robotic Assisted Surgery In Total Knee Replacement
A study testing Triathlon in people with Knee Osteoarthritis, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement. The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Triathlon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Apr 2023to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Listed for elective primary TKR for end stage osteoarthritis
- Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis)
- Male or Female, aged 18 years or above (18-80 at the time of listing for surgery).
- Able to understand and provide written consent.
Who cannot join
- Varus deformity of > 20 degrees observed by consultant on examination
- Patient is unable to comply with the study protocol (incl. refusal for CT scan)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Requires patella resurfacing
- Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University hospital
Gothenburg
Maziar Mohaddes, Associate Professor, MD, 0046313421000, mazmo1@vgregion.se
Mazaíar Mohaddes, Assoc Professor, MD
- Recruiting
Örebro University Hospital, Department of Medical Sciences
Örebro, 705 85
Per Wretenberg, Professor, 0046706636686, per.wretenberg@regionorebrolan.se
Gunnar Falk, MD, 004670-5698284, gunnar.falk@regionorebrolan.se
About this study
Official title: Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial
The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement.
The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score.
Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.
Read the detailed description
Study Title:
Robotic Assisted Surgery in total knee replacement versus Manual Total Knee Arthroplasty: A randomised controlled trial
Type of study:
CE marked device study
Trial Design:
Multi-center site prospective parallel group randomised controlled trial
Trial Participants:
Listed for routine primary total knee replacements
Investigational Device:
MAKO Robotic Arm Assisted Surgical System
Control:
Conventional jig-based surgery
Implant (Intervention and Control):
Triathlon TKR
Planned Sample Size:
200 (100 MAKO, 100 Manual)
Follow-up duration:
24 months following surgery
Planned Trial Period:
Nov 2022 - 2024
Primary Objective:
To compare changes in joint awareness (measured by the Forgotten Joint Score (FJS)20) from baseline to 12 months following TKR between the two groups.
Secondary Objectives
- To compare pain measured using the pain visual analogue scale.
- To compare the health-related quality of life using the EQ5D-3L at baseline, 3, 12 and 24 months.
- To compare changes in knee function in activities of daily living (measured by the Oxford knee score (OKS)19) from baseline to 3, 12 and 24 months.
- To compare changes in clinically assessed pain and stiffness (measured by the Knee Society Score (KSS)) at baseline to 3 and 12 months.
- To compare revision rate using implant migration measured by CTMA at 12 and 24 months as a surrogate marker for revision.
Primary Endpoint:
Functional outcome measured by the changes in joint awareness of the FJS score at 12 months following the intervention.
Secondary Endpoints:
Secondary outcomes will be collected up to 24 months following the intervention.
Device Name:
Both arms will receive Triathlon TKR with a highly crossed linked (X3) cruciate retaining polyethylene insert.
The intervention group will utilise the MAKO robotic arm to make the bone cuts.
- Conditions
- Knee Osteoarthritis
- Being tested
- Triathlon
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriathlonDevice
Total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| MAKO TKA | Experimental | Not described Receives: Device: Triathlon |
| Conventional | Active comparator | Not described Receives: Device: Triathlon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score
Patient-reported outcome
Measured: 1 year
Secondary outcomes (4)
Knee pain
Patient-reported outcome
Measured: 2 years
EQ-5D
Patient-reported outcome
Measured: 3, 12, 24 months
Oxford Knee Score
Patient-reported outcome
Measured: 3, 12, 24 months
Knee Society Score
Physician-reported outcome
Measured: 3, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Apr 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, Maziar Mohaddes Ardebili, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842538
- Sponsor's protocol ID
- RAKER
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05842538
- Acronym / sponsor ID
- RAKER
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 6 May 2023 (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 robotic arm assisted surgery with manual surgery in patients operated with knee replacement.
The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score.
Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.
Detailed description
Study Title:
Robotic Assisted Surgery in total knee replacement versus Manual Total Knee Arthroplasty: A randomised controlled trial
Type of study:
CE marked device study
Trial Design:
Multi-center site prospective parallel group randomised controlled trial
Trial Participants:
Listed for routine primary total knee replacements
Investigational Device:
MAKO Robotic Arm Assisted Surgical System
Control:
Conventional jig-based surgery
Implant (Intervention and Control):
Triathlon TKR
Planned Sample Size:
200 (100 MAKO, 100 Manual)
Follow-up duration:
24 months following surgery
Planned Trial Period:
Nov 2022 - 2024
Primary Objective:
To compare changes in joint awareness (measured by the Forgotten Joint Score (FJS)20) from baseline to 12 months following TKR between the two groups.
Secondary Objectives
- To compare pain measured using the pain visual analogue scale.
- To compare the health-related quality of life using the EQ5D-3L at baseline, 3, 12 and 24 months.
- To compare changes in knee function in activities of daily living (measured by the Oxford knee score (OKS)19) from baseline to 3, 12 and 24 months.
- To compare changes in clinically assessed pain and stiffness (measured by the Knee Society Score (KSS)) at baseline to 3 and 12 months.
- To compare revision rate using implant migration measured by CTMA at 12 and 24 months as a surrogate marker for revision.
Primary Endpoint:
Functional outcome measured by the changes in joint awareness of the FJS score at 12 months following the intervention.
Secondary Endpoints:
Secondary outcomes will be collected up to 24 months following the intervention.
Device Name:
Both arms will receive Triathlon TKR with a highly crossed linked (X3) cruciate retaining polyethylene insert.
The intervention group will utilise the MAKO robotic arm to make the bone cuts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAKO TKA | Experimental | Device: Triathlon |
| Conventional | Active comparator | Device: Triathlon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Listed for elective primary TKR for end stage osteoarthritis
- Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis)
- Male or Female, aged 18 years or above (18-80 at the time of listing for surgery).
- Able to understand and provide written consent.
Key exclusion criteria (6 listed)
- Varus deformity of > 20 degrees observed by consultant on examination
- Patient is unable to comply with the study protocol (incl. refusal for CT scan)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Requires patella resurfacing
- Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
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 |
|---|---|---|
| TriathlonTotal knee arthroplasty | Device | Conventional, MAKO TKA |
Primary outcome
Forgotten Joint Score
Time frame: 1 year
Patient-reported outcome
4 secondary outcomes
Knee pain
Time frame: 2 years
EQ-5D
Time frame: 3, 12, 24 months
Oxford Knee Score
Time frame: 3, 12, 24 months
Knee Society Score
Time frame: 3, 12, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Örebro University Hospital, Department of Medical Sciences
Örebro, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon in people with Knee Osteoarthritis, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 6 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: looking for participants now, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forgotten Joint Score (time frame: 1 year). 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 10 Oct 2023.