Knee ArthroplastyNCT01705366
Clinical Outcomes of Knee Replacement
An observational study of Knee Arthroplasty, run by Northwest Surgical Specialists, Vancouver at 1 site in United States.
Trial summary
The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Non-MAKO® Robot Assisted Total Knee Arthroplasty, MAKO® Robot Assisted Medial Knee Arthroplasty and MAKO® Robot Assisted Medial and PF Knee Arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 19 Sep 2018
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All male and non-pregnant females undergoing knee replacement
Who may be able to join
- requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities
- has failed non-operative management of their joint disease
Who cannot join
- cognitively unable to complete study health-related quality of life forms
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Rebound Orthopedics and Neurosurgery
Vancouver, Washington, 98686
About this study
Official title: Clinical Outcomes of Joint Arthroplasty
The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.
The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.
- Conditions
- Knee Arthroplasty
- Being tested
- Non-MAKO® Robot Assisted Total Knee Arthroplasty, MAKO® Robot Assisted Medial Knee Arthroplasty, MAKO® Robot Assisted Medial and PF Knee Arthroplasty, RESTORIS Multicompartmental Knee System, Depuy Knee Replacement System
- Keywords
- Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease
- Medical subject headings
- Osteoarthritis, Joint Diseases, Arthritis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-MAKO® Robot Assisted Total Knee ArthroplastyProcedure or surgery
Also called TKA, Total Knee Replacement, Revision Knee Arthroplasty
Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.
MAKO® Robot Assisted Medial Knee ArthroplastyProcedure or surgery
Also called Unicompartmental Knee Arthroplasty (UKA)
Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.
MAKO® Robot Assisted Medial and PF Knee ArthroplastyProcedure or surgery
Also called Bi-compartmental Knee Arthroplasty
Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee
RESTORIS Multicompartmental Knee SystemDevice
Also called RESTORIS® MCK MultiCompartmental Knee System, FDA 501K number K090763
The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.
Depuy Knee Replacement SystemDevice
The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
Stryker® Knee Replacement SystemDevice
The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
| Study group | Role | What they receive |
|---|---|---|
| Knee Arthroplasty | Patients undergoing total knee arthroplasty. This may be Non-MAKO® Robot Assisted Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty or MAKO® Robot Assisted Medial and PF Knee Arthroplasty
The Non-MAKO® Robot Assisted Total Knee Arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. The MAKO® Robot Assisted Arthroplasty uses the RESTORIS Multicompartmental Knee System . Receives: Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty; Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty; Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty; Device: RESTORIS Multicompartmental Knee System; Device: Depuy Knee Replacement System; Device: Stryker® Knee Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
Measured: 10 years
Secondary outcomes (1)
American Knee Society Knee Score
The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs.
Measured: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 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 posted12 Oct 2012 (estimated)
- Study startOct 2012
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Why it stopped: Changes in funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Surgical Specialists, Vancouver
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker MAKO Surgical Corp
- Responsible party
- Sponsor
- Investigators
- Todd Borus, MD, Principal investigator, Northwest Surgical Specialists / Rebound Orthopedics and NeurosurgeryDonald Roberts, MD, Principal investigator, Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705366
- Sponsor's protocol ID
- MAKO-01
- Other IDs
- Borus 2015-005
- Status last verified
- Sep 2018
- First submitted
- 9 Oct 2012
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT01705366
- Acronym / sponsor ID
- MAKO-01
- Conditions
- Knee Arthroplasty
- Keywords
- Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Changes in funding.
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Northwest Surgical Specialists, VancouverUniversity, hospital or other
- Collaborators
- Stryker MAKO Surgical Corp
- Study start
- Oct 2012
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 12 Oct 2012 (estimated)
- 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 objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.
The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroplasty | – | Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty, Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty, Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty, Device: RESTORIS Multicompartmental Knee System, Device: Depuy Knee Replacement System, Device: Stryker® Knee Replacement SystemPatients undergoing total knee arthroplasty. This may be Non-MAKO® Robot Assisted Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty or MAKO® Robot Assisted Medial and PF Knee Arthroplasty The Non-MAKO® Robot Assisted Total Knee Arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. The MAKO® Robot Assisted Arthroplasty uses the RESTORIS Multicompartmental Knee System . |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All male and non-pregnant females undergoing knee replacement
Key inclusion criteria (2 listed)
- requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities
- has failed non-operative management of their joint disease
Key exclusion criteria (2 listed)
- cognitively unable to complete study health-related quality of life forms
- pregnant women
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 |
|---|---|---|
| Non-MAKO® Robot Assisted Total Knee ArthroplastyAlso: TKA, Total Knee Replacement, Revision Knee ArthroplastyPatients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee. | Procedure or surgery | Knee Arthroplasty |
| MAKO® Robot Assisted Medial Knee ArthroplastyAlso: Unicompartmental Knee Arthroplasty (UKA)Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee. | Procedure or surgery | Knee Arthroplasty |
| MAKO® Robot Assisted Medial and PF Knee ArthroplastyAlso: Bi-compartmental Knee ArthroplastyPatients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee | Procedure or surgery | Knee Arthroplasty |
| RESTORIS Multicompartmental Knee SystemAlso: RESTORIS® MCK MultiCompartmental Knee System, FDA 501K number K090763The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement. | Device | Knee Arthroplasty |
| Depuy Knee Replacement SystemThe Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement. | Device | Knee Arthroplasty |
| Stryker® Knee Replacement SystemThe Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement. | Device | Knee Arthroplasty |
Primary outcome
Survivorship of Components
Time frame: 10 years
Survivorship of components is defined as knee implant device(s) remaining in patient.
1 secondary outcome
American Knee Society Knee Score
Time frame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery
Results and safety
The study was stopped early (reason given: Changes in funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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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
Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
Donald Roberts, MD principal investigator
Northwest Surgical Specialists / 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 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 2 inclusion and 2 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 26 Sep 2018. 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?
The study was stopped early (reason given: Changes in funding.). 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?
Survivorship of Components (time frame: 10 years). 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 26 Sep 2018.