Knee ArthroplastyNCT01705886
Clinical and Economic Comparison of Robot Assisted Versus Manual Knee Replacement
An observational study of Knee Arthroplasty, run by Northwest Surgical Specialists, Vancouver at 1 site in United States.
Trial summary
The purpose of this study is to document and compare the surgical and after surgery costs, recovery time, and outcomes of two procedure types: Robotic assisted surgery replacing one compartment of the knee Manual (robot is not used) surgery replacing all three compartments of the knee (total knee replacement) The… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Total Knee Arthroplasty, MAKO® Robot Assisted Medial Knee Arthroplasty and RESTORIS Multicompartmental Knee System
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and non-pregnant females undergoing knee replacement who are between 21 and 80 years of age with stable health and are willing and able to have physical therapy.
Who may be able to join
- Age, 21-80 years
- Sex, males and females will be included
- BMI less than or equal to 39
- Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history
- Patient is willing and able to cooperate in follow-up therapy at Rebound facilities in Vancouver, WA
- Patient has stable and functional collateral ligaments
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- Patient or patient's legal representative has signed the Informed Consent form
- Failed non-operative management of their joint disease
- Need to obtain pain relief and improved function
- Moderate or severe pain with either walking or at rest
- Diagnosed with osteoarthritis in one or more compartments of the knee and non-surgical treatment options have failed to provide relief for symptoms
- Patient exhibits preoperative radiographic evidence of joint degeneration that cannot be treated in non-operative fashion
Who cannot join
- Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study
- Patients with pre-op flexion contracture greater than 10 degrees, overall flexion less than 115 degrees, and varus/valgus greater than 10 degrees
- Patient who is on workmen's compensation
- Patients who are on chronic long acting preoperative narcotic pain medication
- Patients with inflammatory polyarthritis
- Women who are pregnant
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- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes
- Subjects who are currently involved in another clinical study with the exception to an outcomes study
- Patients with a pathology which, in the opinion of the Principal Investigator, will adversely affect healing
- A diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
- Patients receiving an isolated patellofemoral UKA,lateral UKA, or bi-compartmental arthroplasty
- Patients with significant medical condition preventing a well-functioning contralateral knee
- cognitively unable to complete study health-related quality of life forms
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 and Economic Comparison of Robotic Versus Manual Knee Arthroplasty
The purpose of this study is to document and compare the surgical and after surgery costs, recovery time, and outcomes of two procedure types:
- Robotic assisted surgery replacing one compartment of the knee
- Manual (robot is not used) surgery replacing all three compartments of the knee (total knee replacement)
The hypothesis is that robot assisted partial knee replacement is cost effective and provides clinical outcomes that are equivalent to a manual total knee replacement.
Read the detailed description
Background and Significance:
The primary indications for joint replacement surgery include severe lower extremity pain that prevents individuals from performing normal daily activities. The level of pain experienced by these patients cannot be managed successfully with oral medications, physical therapy, or joint injections of steroids or hyaluronic acid. The source of the pain most commonly is a result of arthritic changes in the joint; the arthritis may be due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Patients who are appropriate candidates for partial joint replacement surgery also may experience joint stiffness that interferes with their normal daily activities. In addition, there usually is radiographic evidence of changes in the joint caused by the arthritic process. Joint damage is evaluated radiographically in order to classify the severity of the joint disease. Partial joint replacement surgery is performed to replace the diseased parts of the joint with prosthesis. There are a variety of options that surgeons and patients can choose for their joint replacement surgery. There are many different joint replacement component systems manufactured by several different companies; some systems are recommended for particular types of patients while others can be used in a greater number of patients. Recently, new techniques have been introduced that are classified as minimally invasive because they require smaller surgical incisions to implant standard joint prostheses. Patients who are younger, thinner, and in better overall health are usually the best surgical candidates for minimally invasive procedures.
Osteoarthritis affects 40 million Americans and 15 million people in the United States suffer from degenerative arthritis of the knee. Unicondylar knee arthroplasty (UKA) was introduced as a treatment option for degenerative arthritis of the knee in the early 1970's[1]. The procedure initially yielded variable results and this unpredictability resulted in broadly low levels of usage[1]. Recent improvements in the surgical techniques and technology used for UKA have increased the effectiveness of this surgery. As the average age of the United States population increases, this surgical procedure will become even more common. It is estimated by the Millennium Research Group that there will be 55,100 unicondylar knee procedures in 2010 and the compound annual growth rate from 2009 to 2014 will be 8.3%.
UKA knee arthroplasty can be viewed as an attractive alternative to total knee arthroplasty (TKA) assuming the patient's osteoarthritis has remained isolated in a single compartment or two compartments. UKA knee arthroplasty are generally less invasive procedures than TKA. Since the procedure is less invasive there is usually less blood loss; more cartilage, tissue, and bone is sparred, which results in shorter recovery times than TKA. This procedure is attractive to adults who are interested in remaining active pain-free lifestyles as they age.
The cost-effectiveness of healthcare interventions, especially new technology, is becoming essential. Comparing the procedural costs of robotic-assisted surgery and the outcomes of the patients versus TKA, the gold standard, will help substantiate whether robotic-assisted surgery from an economic viewpoint is a cost-effective treatment. In addition the rehabilitation after knee replacement surgery is critical to achieving proper functional outcomes. Information pertaining to knee replacement post discharge costs has been limited. Due to the lack of studies and the continued growth in the number of knee arthroplasty surgeries it is imperative to track post discharge costs of all variables. We will be documenting and comparing the procedural and postoperative costs, recovery time, and outcomes of three procedure types in robotic assisted unicompartmental knee arthroplasty, robotic assisted bicompartmental knee arthroplasty and manual total knee arthroplasty.
- Conditions
- Knee Arthroplasty
- Being tested
- Total Knee Arthroplasty, MAKO® Robot Assisted Medial Knee Arthroplasty, RESTORIS Multicompartmental Knee System, Depuy Knee Replacement System, Stryker® Knee Replacement System
- Keywords
- Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Joint Diseases, Arthritis, Musculoskeletal Diseases, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Also called TKA, Total Knee Replacement
Patients undergoing manual (no robot used) surgery to replace of all 3 compartments of the knee
MAKO® Robot Assisted Medial Knee ArthroplastyProcedure or surgery
Also called unilateral knee arthroplasty (UKA)
Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment 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 knee replacement surgery. This may be a Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty.
The MAKO® Robot Assisted surgeries use the RESTORIS Multicompartmental Knee System.
The total knee arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. Receives: Procedure: Total Knee Arthroplasty; Procedure: MAKO® Robot Assisted Medial 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.
Cost per case at 1 year
Cost per case for 1 year. The inpatient costs, analgesic use, physical therapy, durable medical equipment, and postoperative visits will be used to calculate the cost at 1 year.
Measured: 1 year
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 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 completionJan 2018
- Study completionOct 2023
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Surgical Specialists, Vancouver
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker 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
- NCT01705886
- Sponsor's protocol ID
- MAKO-02
- Other IDs
- 2015-004
- Status last verified
- Nov 2024
- First submitted
- 9 Oct 2012
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Comparison of Robotic Versus Manual Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01705886
- Acronym / sponsor ID
- MAKO-02
- Conditions
- Knee Arthroplasty
- Keywords
- Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease, Knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Northwest Surgical Specialists, VancouverUniversity, hospital or other
- Collaborators
- Stryker Surgical Corp
- Study start
- Oct 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- Oct 2023 (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 purpose of this study is to document and compare the surgical and after surgery costs, recovery time, and outcomes of two procedure types:
- Robotic assisted surgery replacing one compartment of the knee
- Manual (robot is not used) surgery replacing all three compartments of the knee (total knee replacement)
The hypothesis is that robot assisted partial knee replacement is cost effective and provides clinical outcomes that are equivalent to a manual total knee replacement.
Detailed description
Background and Significance:
The primary indications for joint replacement surgery include severe lower extremity pain that prevents individuals from performing normal daily activities. The level of pain experienced by these patients cannot be managed successfully with oral medications, physical therapy, or joint injections of steroids or hyaluronic acid. The source of the pain most commonly is a result of arthritic changes in the joint; the arthritis may be due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Patients who are appropriate candidates for partial joint replacement surgery also may experience joint stiffness that interferes with their normal daily activities. In addition, there usually is radiographic evidence of changes in the joint caused by the arthritic process. Joint damage is evaluated radiographically in order to classify the severity of the joint disease. Partial joint replacement surgery is performed to replace the diseased parts of the joint with prosthesis. There are a variety of options that surgeons and patients can choose for their joint replacement surgery. There are many different joint replacement component systems manufactured by several different companies; some systems are recommended for particular types of patients while others can be used in a greater number of patients. Recently, new techniques have been introduced that are classified as minimally invasive because they require smaller surgical incisions to implant standard joint prostheses. Patients who are younger, thinner, and in better overall health are usually the best surgical candidates for minimally invasive procedures.
Osteoarthritis affects 40 million Americans and 15 million people in the United States suffer from degenerative arthritis of the knee. Unicondylar knee arthroplasty (UKA) was introduced as a treatment option for degenerative arthritis of the knee in the early 1970's[1]. The procedure initially yielded variable results and this unpredictability resulted in broadly low levels of usage[1]. Recent improvements in the surgical techniques and technology used for UKA have increased the effectiveness of this surgery. As the average age of the United States population increases, this surgical procedure will become even more common. It is estimated by the Millennium Research Group that there will be 55,100 unicondylar knee procedures in 2010 and the compound annual growth rate from 2009 to 2014 will be 8.3%.
UKA knee arthroplasty can be viewed as an attractive alternative to total knee arthroplasty (TKA) assuming the patient's osteoarthritis has remained isolated in a single compartment or two compartments. UKA knee arthroplasty are generally less invasive procedures than TKA. Since the procedure is less invasive there is usually less blood loss; more cartilage, tissue, and bone is sparred, which results in shorter recovery times than TKA. This procedure is attractive to adults who are interested in remaining active pain-free lifestyles as they age.
The cost-effectiveness of healthcare interventions, especially new technology, is becoming essential. Comparing the procedural costs of robotic-assisted surgery and the outcomes of the patients versus TKA, the gold standard, will help substantiate whether robotic-assisted surgery from an economic viewpoint is a cost-effective treatment. In addition the rehabilitation after knee replacement surgery is critical to achieving proper functional outcomes. Information pertaining to knee replacement post discharge costs has been limited. Due to the lack of studies and the continued growth in the number of knee arthroplasty surgeries it is imperative to track post discharge costs of all variables. We will be documenting and comparing the procedural and postoperative costs, recovery time, and outcomes of three procedure types in robotic assisted unicompartmental knee arthroplasty, robotic assisted bicompartmental knee arthroplasty and manual total knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroplasty | – | Procedure: Total Knee Arthroplasty, Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty, Device: RESTORIS Multicompartmental Knee System, Device: Depuy Knee Replacement System, Device: Stryker® Knee Replacement SystemPatients undergoing knee replacement surgery. This may be a Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty. The MAKO® Robot Assisted surgeries use the RESTORIS Multicompartmental Knee System. The total knee arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and non-pregnant females undergoing knee replacement who are between 21 and 80 years of age with stable health and are willing and able to have physical therapy.
Key inclusion criteria (12 listed)
- Age, 21-80 years
- Sex, males and females will be included
- BMI less than or equal to 39
- Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history
- Patient is willing and able to cooperate in follow-up therapy at Rebound facilities in Vancouver, WA
Key exclusion criteria (13 listed)
- Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study
- Patients with pre-op flexion contracture greater than 10 degrees, overall flexion less than 115 degrees, and varus/valgus greater than 10 degrees
- Patient who is on workmen's compensation
- Patients who are on chronic long acting preoperative narcotic pain medication
- Patients with inflammatory polyarthritis
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 |
|---|---|---|
| Total Knee ArthroplastyAlso: TKA, Total Knee ReplacementPatients undergoing manual (no robot used) surgery to replace of all 3 compartments of the knee | Procedure or surgery | Knee Arthroplasty |
| MAKO® Robot Assisted Medial Knee ArthroplastyAlso: unilateral knee arthroplasty (UKA)Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment 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
Cost per case at 1 year
Time frame: 1 year
Cost per case for 1 year. The inpatient costs, analgesic use, physical therapy, durable medical equipment, and postoperative visits will be used to calculate the cost at 1 year.
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 after surgery
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 21 Nov 2024.
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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 12 inclusion and 13 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 21 Nov 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 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 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?
Cost per case at 1 year (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 21 Nov 2024.