Total Knee ReplacementPhase 4NCT00160797
Total Knee Arthroplasty Outcome Study
A Phase 4 study testing MIS™ Minimally Invasive Solutions™ TKA System in people with Total Knee Replacement, run by University of Florida.
Trial summary
The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- MIS™ Minimally Invasive Solutions™ TKA System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Oct 2005
- Phase
- Phase 4
- 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
- Presence of a severely disabled joint secondary to painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis that warrants primary knee arthroplasty.
- Gender - Males and females will be included. The male-to-female ratio will depend upon the patient population at each institution conducting the study.
- Age - Minimum of 18 years-old.
- Stable Health - The patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
- Patient or patient's legal representative has read and signed the Letter to the Patient form.
Who cannot join
- Patient is skeletally immature.
- Previous ipsilateral knee arthroplasty.
- Previous Patellectomy.
- Patient is pregnant or breastfeeding.
- Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic, respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
- Patients who have received an investigational drug or device within the last 30 days.
- Patient is unwilling or unable to cooperate in a follow-up program.
About this study
Official title: MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty Outcome Study #02-800
The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.
Read the detailed description
The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. The MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty System has been cleared for use by the Food and Drug Administration.
You are invited to participate in this data collection study, comparing the MIS system to standard knee replacement systems. The decision about which system and operation will be best for you has already been made by you and your orthopaedic surgeon.
The information will be used to compare minimally invasive surgery and the standard surgery procedures. The results of this study will provide information that will add to the knowledge base of knee replacement surgery.
- Conditions
- Total Knee Replacement
- Being tested
- MIS™ Minimally Invasive Solutions™ TKA System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIS™ Minimally Invasive Solutions™ TKA SystemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2005
- Study completionOct 2005
Why it stopped: 10/2005 PI assigned duties as trauma physician in addition other duties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Richard G. Vlasak, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160797
- Sponsor's protocol ID
- 580-2004
- Status last verified
- Apr 2012
- First submitted
- 8 Sep 2005
- Last updated
- 2 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty Outcome Study #02-800
- ClinicalTrials.gov ID
- NCT00160797
- Acronym / sponsor ID
- 580-2004
- Conditions
- Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 10/2005 PI assigned duties as trauma physician in addition other duties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Aug 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Sep 2005 (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 this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.
Detailed description
The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. The MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty System has been cleared for use by the Food and Drug Administration.
You are invited to participate in this data collection study, comparing the MIS system to standard knee replacement systems. The decision about which system and operation will be best for you has already been made by you and your orthopaedic surgeon.
The information will be used to compare minimally invasive surgery and the standard surgery procedures. The results of this study will provide information that will add to the knowledge base of knee replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of a severely disabled joint secondary to painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis that warrants primary knee arthroplasty.
- Gender - Males and females will be included. The male-to-female ratio will depend upon the patient population at each institution conducting the study.
- Age - Minimum of 18 years-old.
- Stable Health - The patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
- Patient or patient's legal representative has read and signed the Letter to the Patient form.
Key exclusion criteria (7 listed)
- Patient is skeletally immature.
- Previous ipsilateral knee arthroplasty.
- Previous Patellectomy.
- Patient is pregnant or breastfeeding.
- Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic, respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
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 |
|---|---|---|
| MIS™ Minimally Invasive Solutions™ TKA System | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
Related trials for Total Knee Replacement
Recruiting
Knee Replacement Rehabilitation Care Pathways
Knee Replacement, Total
RecruitingPhase 3
Suzetrigine in TKA
Total Knee Arthroplasty (TKA), Total Knee Arthroplasty \(TKA\)
Recruiting
Binaural Beats for Postoperative Pain and Anxiety Reduction
TKA, THA
Recruiting
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
Multiple Myeloma, Total Knee Replacement
Not yet recruiting
A Study on the Physiological Outcomes of the Enhanced Recovery After Surgery Model in Older Adults Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty (Replacement)
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.
Richard G. Vlasak, M.D. principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MIS™ Minimally Invasive Solutions™ TKA System in people with Total Knee Replacement, run by University of Florida.
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 5 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: withdrawn, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 2 May 2012; AzTrials last refreshed its copy on 31 Oct 2026.