OsteoarthritisNCT03668717
Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty
An observational study of Osteoarthritis, run by St. Helena Hospital Coon Joint Replacement Institute at 1 site in United States.
Trial summary
The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Robotic-arm assisted medical MCK implant
- Type of treatment
- Medical device
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over 21 years of age who required a primary robotic-arm assisted medial unicompartmental arthroplasty.
Who may be able to join
- All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
- Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
- Patient willing to comply with follow up.
Who cannot join
- Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
- Patient had active infection
- Medial MCK onlay implants were implanted without bone cement
- Patients did not have sufficient bone stock to allow for insertion and fixation of components
- Patient did not have sufficient soft tissue integrity to allow for stability
- Patient had a neurological or muscular deformity that did not allow for control of the knee.
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 the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.
Read the detailed description
The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.
- Conditions
- Osteoarthritis
- Being tested
- Robotic-arm assisted medical MCK implant
- Keywords
- osteoarthritis, medial, unicompartmental
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-arm assisted medical MCK implantDevice
Robotic-arm assisted medical MCK implant system to replace the medial compartment 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 determine the revision rate in this patient population
Measured: 10 year after surgery
Secondary outcomes (1)
% of patients with revisions
To determine the revision rate in this patient population
Measured: 2 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 posted13 Sep 2018
- Study startOct 2011
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
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.
- 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
- Retrospective
- Enrolment
- 133 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
- NCT03668717
- Sponsor's protocol ID
- 004
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2016
- Last updated
- 13 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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03668717
- Acronym / sponsor ID
- 004
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, medial, unicompartmental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (actual)
- Lead sponsor
- St. Helena Hospital Coon Joint Replacement InstituteUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Oct 2011
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 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 the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.
Detailed description
The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
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 required a primary robotic-arm assisted medial unicompartmental arthroplasty.
Key inclusion criteria (3 listed)
- All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
- Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
- Patient willing to comply with follow up.
Key exclusion criteria (6 listed)
- Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
- Patient had active infection
- Medial MCK onlay implants were implanted without bone cement
- Patients did not have sufficient bone stock to allow for insertion and fixation of components
- Patient did not have sufficient soft tissue integrity to allow for stability
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 medical MCK implantRobotic-arm assisted medical MCK implant system to replace the medial compartment of the knee. | Device | – |
Primary outcome
% of patients with revisions
Time frame: 10 year after surgery
To determine the revision rate in this patient population
1 secondary outcome
% of patients with revisions
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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, 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 3 inclusion and 6 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 13 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?
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?
% of patients with revisions (time frame: 10 year 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 13 Sep 2018.