Knee ArthropathyNCT06321952
Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA
A study testing ROSA robotic assist TKA and iassist TKA in people with Knee Arthropathy, run by Mahidol University at 1 site in Thailand.
Trial summary
A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- ROSA robotic assist TKA and iassist TKA
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 17 Sep 2021to 1 Feb 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary osteoarthritis knee with indicated for total knee replacement
- age equal or more than 55 years old
Who cannot join
- revision surgery
- deformity greater than 15º
- Intra/Post operative complication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty
A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.
Read the detailed description
Introduction: Primary total knee arthroplasty is considered the gold standard treatment for end-stage osteoarthritis of the knee. The primary objective of this surgical procedure is to restore mechanical alignment. At Siriraj Hospital, we employ technology to enhance the accuracy of our surgical procedures. The purpose of this study is to compare the accuracy of robotic-assisted surgery (ROSA) and gyroscope-based surgery in primary total knee arthroplasty.
Methods: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.
- Conditions
- Knee Arthropathy
- Being tested
- ROSA robotic assist TKA, iassist TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSA robotic assist TKADevice
Also called iassist TKA
total knee replacement with ROSA robotic assist
iassist TKAProcedure or surgery
total knee replacement with iassist
| Study group | Role | What they receive |
|---|---|---|
| ROSA robotic assist TKA | Active comparator | ROSA robotic assist TKA Receives: Device: ROSA robotic assist TKA |
| iassist TKA | Active comparator | iassist TKA Receives: Procedure: iassist TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument
accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months
Measured: preoperative and postoperative 3months
Secondary outcomes (4)
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
functional outcomes (KOOS score) score 0-100 in each domain of 4 domains 0=worst, 100=good
Measured: preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
functional outcomes (Oxford knee score) score 0-48 0=worst, 48=good
Measured: preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
functional outcomes (EQ-5D-5L) score 5-25, score5=good, 25=worst
Measured: preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
functional outcomes (range of motion)
Measured: preoperative and postoperative 3months and 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start17 Sep 2021
- Primary completion22 Oct 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321952
- Sponsor's protocol ID
- GTanareesuchoti
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06321952
- Acronym / sponsor ID
- GTanareesuchoti
- Conditions
- Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 20 Mar 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.
A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.
Detailed description
Introduction: Primary total knee arthroplasty is considered the gold standard treatment for end-stage osteoarthritis of the knee. The primary objective of this surgical procedure is to restore mechanical alignment. At Siriraj Hospital, we employ technology to enhance the accuracy of our surgical procedures. The purpose of this study is to compare the accuracy of robotic-assisted surgery (ROSA) and gyroscope-based surgery in primary total knee arthroplasty.
Methods: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| ROSA robotic assist TKA | Active comparator | Device: ROSA robotic assist TKAROSA robotic assist TKA |
| iassist TKA | Active comparator | Procedure: iassist TKAiassist TKA |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary osteoarthritis knee with indicated for total knee replacement
- age equal or more than 55 years old
Key exclusion criteria (3 listed)
- revision surgery
- deformity greater than 15º
- Intra/Post operative complication
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 |
|---|---|---|
| ROSA robotic assist TKAAlso: iassist TKAtotal knee replacement with ROSA robotic assist | Device | ROSA robotic assist TKA |
| iassist TKAtotal knee replacement with iassist | Procedure or surgery | iassist TKA |
Primary outcome
accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument
Time frame: preoperative and postoperative 3months
accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months
4 secondary outcomes
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
Time frame: preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
Time frame: preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
Time frame: preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
Time frame: preoperative and postoperative 3months and 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROSA robotic assist TKA and iassist TKA in people with Knee Arthropathy, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Mar 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 Thailand. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument (time frame: preoperative and postoperative 3months). 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 20 Mar 2024.