Osteoarthritis, KneeNCT03106558
Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
A study testing Total Knee Arthroplasty using Manual Instrumentation and Total Knee Arthroplasty using Robotic Arm in people with Osteoarthritis, Knee, run by Rothman Institute Orthopaedics at 4 sites in United States.
Trial summary
This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Total Knee Arthroplasty using Manual Instrumentation and Total Knee Arthroplasty using Robotic Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2016to Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires primary total knee surgery
- Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
- Patient is willing to sign an IRB approved informed consent
- Patient is at least 18 years of age
Who cannot join
- Patient has a BMI > 50
- Patient is skeletally immature
- Patient has an active infection or suspected infection in or about the joint
- Bone stock that is inadequate to support fixation of the prosthesis
- Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
- Patients with mental or neurological conditions which may be incapable of following instructions.
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- Blood supply limitations
- Collateral ligament insufficiency.
- Patients with prior HTOs or Unis.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Athens Orthopedic Clinic
Athens, Georgia, 30606
Cleveland Clinic
Cleveland, Ohio, 44195
Rothman Institute
Egg Harbor, New Jersey, 08234
Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Total Knee Arthroplasty using Manual Instrumentation, Total Knee Arthroplasty using Robotic Arm
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty using Manual InstrumentationDevice
Total Knee Arthroplasty using Robotic ArmDevice
| Study group | Role | What they receive |
|---|---|---|
| Manual instrument total knee replacement | Active comparator | Not described Receives: Device: Total Knee Arthroplasty using Manual Instrumentation |
| Robitic arm total knee replacement | Active comparator | Not described Receives: Device: Total Knee Arthroplasty using Robotic Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Component alignment
CT scan measurement
Measured: 6 weeks post knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106558
- Sponsor's protocol ID
- 2017WHoz
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03106558
- Acronym / sponsor ID
- 2017WHoz
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 10 Apr 2017 (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 is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual instrument total knee replacement | Active comparator | Device: Total Knee Arthroplasty using Manual Instrumentation |
| Robitic arm total knee replacement | Active comparator | Device: Total Knee Arthroplasty using Robotic Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient requires primary total knee surgery
- Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
- Patient is willing to sign an IRB approved informed consent
- Patient is at least 18 years of age
Key exclusion criteria (9 listed)
- Patient has a BMI > 50
- Patient is skeletally immature
- Patient has an active infection or suspected infection in or about the joint
- Bone stock that is inadequate to support fixation of the prosthesis
- Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
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 Arthroplasty using Manual Instrumentation | Device | Manual instrument total knee replacement |
| Total Knee Arthroplasty using Robotic Arm | Device | Robitic arm total knee replacement |
Primary outcome
Component alignment
Time frame: 6 weeks post knee arthroplasty
CT scan measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Arthroplasty using Manual Instrumentation and Total Knee Arthroplasty using Robotic Arm in people with Osteoarthritis, Knee, run by Rothman Institute Orthopaedics at 4 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 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 4 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?
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?
Component alignment (time frame: 6 weeks post knee arthroplasty). 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 10 Apr 2017.