Unicompartmental Knee ArthroplastyNCT01845597
Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement
An observational study of Unicompartmental Knee Arthroplasty, run by Northwest Surgical Specialists, Vancouver at 1 site in United States.
Trial summary
The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Unicompartmental Knee Arthroplasty
- What is being tested?
- MAKOplasty® medial UKA
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 28 Feb 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent a MAKOplasty procedure by the investigating surgeon and received a medial MCK onlay implant.
Who may be able to join
- over 21 years of age
- underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon
- at least 24 months post-operative
Who cannot join
- Patients will be excluded from participation in the study if they are cognitively unable to answer study questions
Trial locations and contacts
1 site in 1 country.
United States1 site
Rebound Orthopedics and Neurosurgery
Vancouver, Washington, 98686
About this study
Official title: Survivorship and Outcomes of Robotically Assisted Medial UKA
The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.
Read the detailed description
The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.
- Conditions
- Unicompartmental Knee Arthroplasty
- Being tested
- MAKOplasty® medial UKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAKOplasty® medial UKAProcedure or surgery
Also called Medial Partial Knee Replacement, Medial Unilateral Knee Arthroplasty, Robot Assisted Partial Knee Replacement
A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
| Study group | Role | What they receive |
|---|---|---|
| MAKOplasty® medial UKA | Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. Receives: Procedure: MAKOplasty® medial UKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Year Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
Measured: 10 years after surgery
Secondary outcomes (2)
5 Year Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
Measured: 5 years after surgery
2 Year Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unicompartmental Knee ArthroplastyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Surgical Specialists, Vancouver
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Sponsor
- Investigators
- Todd Borus, MD, Principal investigator, Rebound Orthopedics and Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845597
- Sponsor's protocol ID
- MAKO-03
- Other IDs
- 2016-006
- Status last verified
- Aug 2022
- First submitted
- 29 Apr 2013
- Last updated
- 13 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship and Outcomes of Robotically Assisted Medial UKA
- ClinicalTrials.gov ID
- NCT01845597
- Acronym / sponsor ID
- MAKO-03
- Conditions
- Unicompartmental Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Northwest Surgical Specialists, VancouverUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- Apr 2013
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 13 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.
Detailed description
The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAKOplasty® medial UKA | – | Procedure: MAKOplasty® medial UKAPatients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent a MAKOplasty procedure by the investigating surgeon and received a medial MCK onlay implant.
Key inclusion criteria (3 listed)
- over 21 years of age
- underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon
- at least 24 months post-operative
Key exclusion criteria (1 listed)
- Patients will be excluded from participation in the study if they are cognitively unable to answer study questions
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 |
|---|---|---|
| MAKOplasty® medial UKAAlso: Medial Partial Knee Replacement, Medial Unilateral Knee Arthroplasty, Robot Assisted Partial Knee ReplacementA robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee. | Procedure or surgery | MAKOplasty® medial UKA |
Primary outcome
10 Year Survivorship of Components
Time frame: 10 years after surgery
Survivorship of components is defined as knee implant device(s) remaining in patient.
2 secondary outcomes
5 Year Survivorship of Components
Time frame: 5 years after surgery
2 Year Survivorship of Components
Time frame: 2 years after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Todd Borus, MD principal investigator
Rebound Orthopedics and Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unicompartmental Knee Arthroplasty, run by Northwest Surgical Specialists, Vancouver at 1 site in United States.
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 1 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 13 Jul 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
10 Year Survivorship of Components (time frame: 10 years after surgery). 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 13 Jul 2023.