Osteoarthritis, KneeNCT03954912
Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty
A study testing MAKO assisted unicondylar knee arthroplasty and NAVIO assisted unicondylar knee arthroplasty in people with Osteoarthritis, Knee and Arthropathy of Knee, run by Ramathibodi Hospital.
Trial summary
This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee, Arthropathy of Knee
- What is being tested?
- MAKO assisted unicondylar knee arthroplasty and NAVIO assisted unicondylar knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Jan 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients were those deemed suitable for unicondylar knee arthroplasty surgery
- patients who could give informed consent
- patients who willing to attend the prescribed follow-up.
Who cannot join
- Patients who have medial osteoarthritis knee with following condition:
- Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).
- Inflammatory arthritis
- A deformity requiring augmentation
- Neurological movement disorders
- pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations
- Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.
About this study
Official title: Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty
Read the detailed description
this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee
- Being tested
- MAKO assisted unicondylar knee arthroplasty, NAVIO assisted unicondylar knee arthroplasty
- Keywords
- MAKO, NAVIO, robotic surgery, UKA, surgical time, KSS, KFS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAKO assisted unicondylar knee arthroplastyProcedure or surgery
MAKO assisted
NAVIO assisted unicondylar knee arthroplastyProcedure or surgery
NAVIO assisted
| Study group | Role | What they receive |
|---|---|---|
| MAKO robotic assisted UKA | Active comparator | image base (MAKO) robotic assisted UKA Receives: Procedure: MAKO assisted unicondylar knee arthroplasty |
| NAVIO robotic assisted UKA | Active comparator | imageless (NAVIO) robotic assisted UKA Receives: Procedure: NAVIO assisted unicondylar knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
operative time in minutes the higher value of blood loss is worse outcome
Measured: 1 day
calculated total blood loss
total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin
Measured: 1 day
Secondary outcomes (1)
post operative complications
post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Jun 2015
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective cohort study
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bhumibol Adulyadej Hospital
- Responsible party
- Principal investigator, Jatupon Kongtharvonskul, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954912
- Sponsor's protocol ID
- 2/62
- Status last verified
- Jun 2019
- First submitted
- 13 May 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leelasestaporn C, Tarnpichprasert T, Arirachakaran A, Kongtharvonskul J. Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. Knee Surg Relat Res. 2020 Mar 12;32(1):13. doi: 10.1186/s43019-020-00030-x.
PubMed 32660619
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03954912
- Acronym / sponsor ID
- 2/62
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee
- Keywords
- MAKO, NAVIO, robotic surgery, UKA, surgical time, KSS, KFS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Bhumibol Adulyadej Hospital
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 17 May 2019 (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.
This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty
Detailed description
this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| MAKO robotic assisted UKA | Active comparator | Procedure: MAKO assisted unicondylar knee arthroplastyimage base (MAKO) robotic assisted UKA |
| NAVIO robotic assisted UKA | Active comparator | Procedure: NAVIO assisted unicondylar knee arthroplastyimageless (NAVIO) robotic assisted UKA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients were those deemed suitable for unicondylar knee arthroplasty surgery
- patients who could give informed consent
- patients who willing to attend the prescribed follow-up.
Key exclusion criteria (7 listed)
- Patients who have medial osteoarthritis knee with following condition:
- Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.
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 |
|---|---|---|
| MAKO assisted unicondylar knee arthroplastyMAKO assisted | Procedure or surgery | MAKO robotic assisted UKA |
| NAVIO assisted unicondylar knee arthroplastyNAVIO assisted | Procedure or surgery | NAVIO robotic assisted UKA |
Primary outcome
operative time
Time frame: 1 day
operative time in minutes the higher value of blood loss is worse outcome
calculated total blood loss
Time frame: 1 day
total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin
1 secondary outcome
post operative complications
Time frame: 12 months
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 Jun 2019.
- Derived from this study: PubMed 32660619Leelasestaporn C, Tarnpichprasert T, Arirachakaran A, Kongtharvonskul J. Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. Knee Surg Relat Res. 2020 Mar 12;32(1):13. doi: 10.1186/s43019-020-00030-x.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing MAKO assisted unicondylar knee arthroplasty and NAVIO assisted unicondylar knee arthroplasty in people with Osteoarthritis, Knee and Arthropathy of Knee, run by Ramathibodi Hospital.
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 3 inclusion and 7 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
operative time (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT03954912, which also lists 1 linked publication.
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 Jun 2019.