OsteoarthritisNCT02058069

Robotic Arm Assisted Total Knee Arthroplasty

A study testing Robotic Arm Assisted Total Knee Arthroplasty in people with Osteoarthritis and Rheumatoid Arthritis, run by MAKO Surgical Corp. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB). The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
What is being tested?: Robotic Arm Assisted Total Knee Arthroplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 3 sitesUnited States
Study dates: Feb 2014to Jan 2015
Phase: Interventional
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

Who may be able to join

Male or female subjects may be recruited in to the Investigation.
Age - The subject must be at least 21 years of age and skeletally mature as demonstrated radiographically by complete closure of the distal femoral and proximal tibial epiphyses.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Investigators and Approved Study Staff, are able to understand this Investigation and cooperate with the Investigation procedures and are willing to comply with all the required post-operative follow-ups.
Subjects who require a total knee arthroplasty for primary surgical management of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, moderate deformities or femoral condyle osteonecrosis as defined below.
Osteoarthritis: Kellgren-Lawrence Grade 3 or higher, with clinical history of an absence of major trauma to the joint; symptoms of pain, stiffness, swelling, and/or loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes.

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Post-Traumatic Arthritis: Kellgren-Lawrence Grade 3 or higher, with a clinical history of trauma to the targeted knee and subsequent pain, stiffness, swelling and loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes.
Rheumatoid Arthritis: American College of Rheumatology classification score of 6 or higher, with a clinical history that demonstrates the following: morning stiffness for at least 1 hour and present for at least 6 weeks, swelling, loss of motion, and/or serum rheumatoid factor; and radiographic findings of narrow joint space, peri-articular osteopenia, and/or per-articular erosions.
Moderate Deformities: Moderate varus, valgus, flexion, or post-traumatic deformities of no more than 15° assessed radiographically. Moderate recurvatum of no more than 8° assessed radiographically.
Femoral Condyle Osteonecrosis: Loss of blood supply in the femoral condyle characterized by sudden onset of pain, possibly triggered by a specific seemingly routine activity or minor injury. Pain is often increased with activity and at night time and may cause swelling of the knee and sensitivity to touch and pressure and may result in limited motion. Confirmed by a bone scan, MRI, and/or x-ray.
Subjects whose anatomy is appropriate for the available range of implant sizes.

Who cannot join

Patients who have had previous surgical procedures requiring implantation of hardware in their operative side knee, hip, or ankle that would result in metal artifact scatter in a CT scan.
Patients who have a fracture malunion of the distal femur or proximal tibia within 12cm of the knee center, assessed radiographically.
Patients who are pregnant, may become pregnant during the course of the Investigation, or are currently lactating.
Patients with allergies or suspected sensitivity to any patient-contacting component of the investigational device or the implant to be used in the study as listed below:
Femoral component: Cobalt Chromium alloy (CoCr)
Tibial component: Titanium alloy (Ti6Al4V)

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Tibial inserts and patella component: Vitamin E infused ultra-high molecular weight polyethylene (UHMWPE)
Saw blade: 440C Stainless Steel
Patients who require bilateral total knee arthroplasty.
Patients who are currently on medical leave from their employment due to Workmen's Compensation.
Patients who are currently state or federal prisoners.
Patients who are currently Wards of the state.
Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery i.e.: clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c > 10 mg/dL) or previous history of joint infection.
Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes.
Patients who are currently involved in another clinical study with an investigational device.
Patients with current litigation pending related to medical treatment of any sort.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
Coon Joint Replacement Institue; St. Helena Hospital
St. Helena, California, 94574
Florida Orthopedic Institute
Tampa, Florida, 33637

Other trials in United States

About this study

The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB).

The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows:

Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up.
Secondary Objective: Radiographic assessment of post-operative limb alignment.
Supporting Objective: Patient assessment of post-operative function and satisfaction.

Conditions: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
Being tested: Robotic Arm Assisted Total Knee Arthroplasty
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Robotic Arm Assisted Total Knee ArthroplastyDevice
Also called MAKO Surgical Corp, RIO Total Knee Arthroplasty Application, MAKOplasty Total Knee Arthroplasty
The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).

Study groups in NCT02058069
Study group	Role	What they receive
Robotic Assisted Total Knee Arthroplasty	Experimental	Not described Receives: Device: Robotic Arm Assisted Total Knee Arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Intra-Operative Complications
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Measured: Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.
Intra-Operative Complications
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Measured: Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.
Intra-Operative Complications
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Measured: 3 Month Post Op

Secondary outcomes (2)

Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative
Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.
Measured: pre-op plan, 3 Month Post Op
Participants With Limb Alignment Difference <4.38 Degrees
The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure.
Measured: Pre-op Plan, 3 Month Post Op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jan 2015

First posted7 Feb 2014 (estimated)
Study startFeb 2014
Primary completionJan 2015
Study completionJan 2015

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 OsteoarthritisStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02058069
Sponsor's protocol ID: RIOTKA_2014
Other IDs: 20131148
Status last verified: Mar 2017
First submitted: 3 Feb 2014
Last updated: 18 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robotic Arm Assisted Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT02058069
Acronym / sponsor ID: RIOTKA_2014
Conditions: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: MAKO Surgical Corp.Industry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 7 Feb 2014 (estimated)
Results: Posted 12 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB).

Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up.
Secondary Objective: Radiographic assessment of post-operative limb alignment.
Supporting Objective: Patient assessment of post-operative function and satisfaction.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Robotic Assisted Total Knee Arthroplasty	Experimental	Device: Robotic Arm Assisted Total Knee Arthroplasty

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female subjects may be recruited in to the Investigation.
Age - The subject must be at least 21 years of age and skeletally mature as demonstrated radiographically by complete closure of the distal femoral and proximal tibial epiphyses.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Investigators and Approved Study Staff, are able to understand this Investigation and cooperate with the Investigation procedures and are willing to comply with all the required post-operative follow-ups.
Subjects who require a total knee arthroplasty for primary surgical management of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, moderate deformities or femoral condyle osteonecrosis as defined below.

Key exclusion criteria (16 listed)

Patients who have had previous surgical procedures requiring implantation of hardware in their operative side knee, hip, or ankle that would result in metal artifact scatter in a CT scan.
Patients who have a fracture malunion of the distal femur or proximal tibia within 12cm of the knee center, assessed radiographically.
Patients who are pregnant, may become pregnant during the course of the Investigation, or are currently lactating.
Patients with allergies or suspected sensitivity to any patient-contacting component of the investigational device or the implant to be used in the study as listed below:
Femoral component: Cobalt Chromium alloy (CoCr)

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
Robotic Arm Assisted Total Knee ArthroplastyAlso: MAKO Surgical Corp, RIO Total Knee Arthroplasty Application, MAKOplasty Total Knee ArthroplastyThe total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).	Device	Robotic Assisted Total Knee Arthroplasty

Primary outcome

Intra-Operative Complications
Time frame: Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Intra-Operative Complications
Time frame: Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Intra-Operative Complications
Time frame: 3 Month Post Op
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.

2 secondary outcomes

Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative
Time frame: pre-op plan, 3 Month Post Op
Participants With Limb Alignment Difference <4.38 Degrees
Time frame: Pre-op Plan, 3 Month Post Op

Results and safety

Results posted to the registry on 12 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Robotic Assisted Total Knee Arthroplasty	100	89

Primary outcome: Intra-Operative Complications

Time frame: Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.. Number. Unit: intra-operative complications

Measure	Robotic Assisted Total Knee Arthroplasty n = 89
Value	0

Population analysed: participants = knees.

Primary outcome: Intra-Operative Complications

Time frame: Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.. Number. Unit: intra-operative complications

Measure	Robotic Assisted Total Knee Arthroplasty n = 89
Value	0

Population analysed: participants = knees.

Primary outcome: Intra-Operative Complications

Time frame: 3 Month Post Op. Number. Unit: intra-operative complications

Measure	Robotic Assisted Total Knee Arthroplasty n = 89
Value	0

Robotic Assisted Total Knee Arthroplasty: Rare Adverse Event Rate: 0

Population analysed: participants = knees.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subject enrollment to end of study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Robotic Assisted Total Knee Arthroplasty	9 of 100 (9%)	0 of 100 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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.

Kenneth Gustke, MD principal investigator

Florida Orthopedic Institute, Tampa General Hospital

Thomas Coon, MD principal investigator

Coon Joint Replacement Institute, St. Helena Hospital

Stefan Kreuzer, MD principal investigator

Memorial Bone and Joint Research Foundation, Memorial Hermann Medical Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Robotic Arm Assisted Total Knee Arthroplasty in people with Osteoarthritis and Rheumatoid Arthritis, run by MAKO Surgical Corp. 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 11 inclusion and 16 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 18 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2016). 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?

Intra-Operative Complications (time frame: Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.). The study lists 3 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 NCT02058069.

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 18 Apr 2017.