Osteoarthritis, KneeNCT03668691
Clinical Outcomes of Joint Arthroplasty
An observational study of Osteoarthritis, Knee, run by St. Helena Hospital Coon Joint Replacement Institute at 1 site in United States.
Trial summary
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Robotic-arm assisted partial knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 patients over 21 years of age who require a primary robotic-arm assisted partial knee replacement.
Who may be able to join
- All patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. These patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities.
Who cannot join
- Patient had an active infection
- Onlay implants were implanted without bone cement
- Patient does not have enough bone stock to allow for insertion and fixation of the components
- Patient does not have sufficient soft tissue integrity to allow for stability
- Patient has a neurological or muscular deformity that did not allow for control of the knee
- Patient will be excluded from participation in the study if they are cognitively unable to answer study questions
- Pregnant women are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Helena Hospital Coon Joint Replacement Institute
St. Helena, California, 94574
About this study
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.
Read the detailed description
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Robotic-arm assisted partial knee arthroplasty
- Keywords
- osteoarthritis, medial unicompartmental, lateral unicompartmental, bicompartmental, patellofemoral
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-arm assisted partial knee arthroplastyDevice
Robotic-arm assisted medial unicompartmental knee arthroplasty, lateral unicompartmental knee arthroplasty, bicompartmental knee arthroplasty, patellofemoral knee arthroplasty implants. A robotic arm assisted unicompartmental or bicompartmental knee arthroplasty procedure to replace the medial or lateral and /or patellofemoral compartments of the knee.
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with Revisions
To assess the revision rate of this patient population
Measured: 10 years after surgery
Secondary outcomes (1)
Patient satisfaction rate
To assess level of patient satisfaction using a questionnaire.
Measured: 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 Sep 2018
- Study startJul 2011
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Helena Hospital Coon Joint Replacement Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Thomas Coon, MD, Principal investigator, St. Helena Hospital Coon Joint Replacement Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668691
- Sponsor's protocol ID
- 002
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2016
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 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
- NCT03668691
- Acronym / sponsor ID
- 002
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, medial unicompartmental, lateral unicompartmental, bicompartmental, patellofemoral
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- St. Helena Hospital Coon Joint Replacement InstituteUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Jul 2011
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Sep 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.
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.
Detailed description
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 21 years of age who require a primary robotic-arm assisted partial knee replacement.
Key inclusion criteria (1 listed)
- All patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. These patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities.
Key exclusion criteria (7 listed)
- Patient had an active infection
- Onlay implants were implanted without bone cement
- Patient does not have enough bone stock to allow for insertion and fixation of the components
- Patient does not have sufficient soft tissue integrity to allow for stability
- Patient has a neurological or muscular deformity that did not allow for control of the knee
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 partial knee arthroplastyRobotic-arm assisted medial unicompartmental knee arthroplasty, lateral unicompartmental knee arthroplasty, bicompartmental knee arthroplasty, patellofemoral knee arthroplasty implants. A robotic arm assisted unicompartmental or bicompartmental knee arthroplasty procedure to replace the medial or lateral and /or patellofemoral compartments of the knee. | Device | – |
Primary outcome
% of patients with Revisions
Time frame: 10 years after surgery
To assess the revision rate of this patient population
1 secondary outcome
Patient satisfaction rate
Time frame: 10 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- 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.
Thomas Coon, MD principal investigator
St. Helena Hospital Coon Joint Replacement Institute
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 Osteoarthritis, Knee, run by St. Helena Hospital Coon Joint Replacement Institute 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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 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?
This study is still under way. Results are not available in the source record yet.
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?
% of patients with Revisions (time frame: 10 years after surgery). 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 12 Sep 2018.