Patellofemoral Knee ArthroplastyNCT01947686
Survivorship and Outcomes of Robotically Assisted Patellofemoral UKA
An observational study of Patellofemoral Knee Arthroplasty, run by St. Helena Hospital Coon Joint Replacement Institute at 2 sites in United States.
Trial summary
The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Patellofemoral Knee Arthroplasty
- What is being tested?
- Robotically guided patellofemoral UKA isolated patellofemoral implants
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Feb 2023
- 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: Patients who underwent a primary robotically guided UKA and received an isolated patellofemoral implant.
Who may be able to join
- Over 21 years of age underwent primary robotically guided UKA and received an isolated patellofemoral implant at least 24 months post operative as of February 2013
Who cannot join
- Patient will be excluded from participation in the study if they are cognitively unable to answer study questions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Helena Hospital Coon Joint Replacement Institute
St. Helena, California, 94574
Rebound Orthopedics and Neurosurgery
Vancouver, Washington, 98686
About this study
The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.
Read the detailed description
The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.
- Conditions
- Patellofemoral Knee Arthroplasty
- Being tested
- Robotically guided patellofemoral UKA isolated patellofemoral implants
- Keywords
- osteoarthritis, patellofemoral
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotically guided patellofemoral UKA isolated patellofemoral implantsDevice
A robot guided isolated patellofemoral unicompartmental knee arthroplasty procedures to replace only the patellofemoral component of the knee.
| Study group | Role | What they receive |
|---|---|---|
| Patellofemoral Knee Arthroplasty | Patient who have received a robotically guided isolated patellofemoral implant. Receives: Device: Robotically guided patellofemoral UKA isolated patellofemoral implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 year survivorship of robotically guided isolated patellofemoral implants.
10 year survivorship of robotically guided isolated patellofemoral implants at 2,5, and 10 year follow up.
Measured: 10 years after surgery
Secondary outcomes (2)
2 year survivorship of robotically guided isolated patellofemoral implants.
The survivorship rate of robotically guided isolated patellofemoral implants at 2,5, and 10 year.
Measured: 2 years after surgery
5 year survivorship of robotically guided isolated patellofemoral implants.
The survivorship rate of robotically guided isolated patellofemoral implants at 2,5, and 10 years post operative.
Measured: 5 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 posted20 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Knee ArthroplastyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Helena Hospital Coon Joint Replacement Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rebound Orthopedics and Neurosurgery
- Responsible party
- Sponsor
- Investigators
- Thomas Coon, MD, Study director, St. Helena Hospital Coon Joint ReplacementTodd Borus, MD, Principal investigator, Rebound Orthopedics and Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947686
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2013
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship and Outcomes of Robotically Assisted Patellofemoral UKA
- ClinicalTrials.gov ID
- NCT01947686
- Acronym / sponsor ID
- 001
- Conditions
- Patellofemoral Knee Arthroplasty
- Keywords
- osteoarthritis, patellofemoral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Helena Hospital Coon Joint Replacement InstituteUniversity, hospital or other
- Collaborators
- Rebound Orthopedics and Neurosurgery
- Study start
- Feb 2013
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 20 Sep 2013 (estimated)
- 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 rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.
Detailed description
The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patellofemoral Knee Arthroplasty | – | Device: Robotically guided patellofemoral UKA isolated patellofemoral implantsPatient who have received a robotically guided isolated patellofemoral implant. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent a primary robotically guided UKA and received an isolated patellofemoral implant.
Key inclusion criteria (1 listed)
- Over 21 years of age underwent primary robotically guided UKA and received an isolated patellofemoral implant at least 24 months post operative as of February 2013
Key exclusion criteria (1 listed)
- Patient will be excluded from participation in the study if they are cognitively unable to answer study questions.
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 |
|---|---|---|
| Robotically guided patellofemoral UKA isolated patellofemoral implantsA robot guided isolated patellofemoral unicompartmental knee arthroplasty procedures to replace only the patellofemoral component of the knee. | Device | Patellofemoral Knee Arthroplasty |
Primary outcome
10 year survivorship of robotically guided isolated patellofemoral implants.
Time frame: 10 years after surgery
10 year survivorship of robotically guided isolated patellofemoral implants at 2,5, and 10 year follow up.
2 secondary outcomes
2 year survivorship of robotically guided isolated patellofemoral implants.
Time frame: 2 years after surgery
5 year survivorship of robotically guided isolated patellofemoral implants.
Time frame: 5 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 5 Sep 2018.
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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 study director
St. Helena Hospital Coon Joint Replacement
Todd Borus, MD principal investigator
Rebound Orthopedics and Neurosurgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Knee Arthroplasty, run by St. Helena Hospital Coon Joint Replacement Institute at 2 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 1 inclusion and 1 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 5 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 2 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?
10 year survivorship of robotically guided isolated patellofemoral implants. (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 5 Sep 2018.