OsteoarthritisNCT03482349
RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
A study testing Total Knee Robotically-Assisted in people with Osteoarthritis, run by Mayo Clinic at 3 sites in United States.
Trial summary
This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Knee Robotically-Assisted
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Mar 2018to 13 Mar 2025
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis
- All eligible male or female patients between the ages of 20 years to 100 years old
- All included study participants must be able to give an informed consent.
Who cannot join
- Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
- The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- Presence of previous prosthetic knee replacement devices (of any type)
- Metastatic disease
- Psychiatric illness
- Drug or alcohol abuse
- Body mass index (BMI) > 40 kg/m2
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.
Read the detailed description
Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.
A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary TKA.
- Conditions
- Osteoarthritis
- Being tested
- Total Knee Robotically-Assisted
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Robotically-AssistedProcedure or surgery
The surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Robotically-Assisted | Experimental | The intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot. Receives: Procedure: Total Knee Robotically-Assisted |
| Total Knee Manual-Executed by Surgeon | No intervention | Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Parameters
Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start16 Mar 2018
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew P Abdel, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482349
- Sponsor's protocol ID
- 17-002188
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2018
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
- ClinicalTrials.gov ID
- NCT03482349
- Acronym / sponsor ID
- 17-002188
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 29 Mar 2018 (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 study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.
Detailed description
Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.
A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Robotically-Assisted | Experimental | Procedure: Total Knee Robotically-AssistedThe intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot. |
| Total Knee Manual-Executed by Surgeon | No intervention | –Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis
- All eligible male or female patients between the ages of 20 years to 100 years old
- All included study participants must be able to give an informed consent.
Key exclusion criteria (8 listed)
- Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
- The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- Presence of previous prosthetic knee replacement devices (of any type)
- Metastatic disease
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 Robotically-AssistedThe surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot. | Procedure or surgery | Total Knee Robotically-Assisted |
Primary outcome
Radiographic Parameters
Time frame: 1 year
Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view
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 14 Mar 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Matthew P Abdel principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Robotically-Assisted in people with Osteoarthritis, run by Mayo Clinic at 3 sites 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 8 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Radiographic Parameters (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 14 Mar 2025.