Gonarthrosis Patients Who Need Artificial Knee Joint Total ReplacementNCT01010828
Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System
A study testing Incision technique in people with Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement, run by Zimmer Biomet at 1 site in Japan.
Trial summary
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement
- What is being tested?
- Incision technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2009to 31 Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects.
Who cannot join
- Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Hospital Organization, Osaka National Hospital
Osaka, 540-0006
About this study
Official title: Efficacy and Safety of Vanguard PS Knee Joint System Using MIS Technique
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.
- Being tested
- Incision technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incision techniqueProcedure or surgery
Tri-Vector Approach retains the majority of 3 vectors of quadriceps.
Incision techniqueProcedure or surgery
Mini Mid-Vastus Approach
| Study group | Role | What they receive |
|---|---|---|
| Tri-Vector Approach | Active comparator | Not described Receives: Procedure: Incision technique |
| Mini Mid-Vastus Approach | Experimental | Not described Receives: Procedure: Incision technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force from femoral and tibial side to retract and bring visual field into view
Measured: intraoperatively
Secondary outcomes (2)
Incision length
Measured: intraoperatively
Visual determination of the extension and flexion gap
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study start1 Oct 2009
- Primary completion31 Mar 2012
- Study completion31 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonarthrosis Patients Who Need Artificial Knee Joint Total ReplacementStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet Japan, Inc.
- Responsible party
- Sponsor
- Investigators
- Takashi Miyamoto, MD, Principal investigator, Osaka Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010828
- Sponsor's protocol ID
- JP12
- Status last verified
- Mar 2019
- First submitted
- 9 Nov 2009
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vanguard PS Knee Joint System Using MIS Technique
- ClinicalTrials.gov ID
- NCT01010828
- Acronym / sponsor ID
- JP12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet Japan, Inc.
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 31 Mar 2012 (actual)
- Study completion
- 31 Mar 2012 (actual)
- First posted
- 10 Nov 2009 (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.
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tri-Vector Approach | Active comparator | Procedure: Incision technique |
| Mini Mid-Vastus Approach | Experimental | Procedure: Incision technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects.
Key exclusion criteria (1 listed)
- Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)
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 |
|---|---|---|
| Incision techniqueTri-Vector Approach retains the majority of 3 vectors of quadriceps. | Procedure or surgery | Tri-Vector Approach |
| Incision techniqueMini Mid-Vastus Approach | Procedure or surgery | Mini Mid-Vastus Approach |
Primary outcome
Force from femoral and tibial side to retract and bring visual field into view
Time frame: intraoperatively
2 secondary outcomes
Incision length
Time frame: intraoperatively
Visual determination of the extension and flexion gap
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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.
Takashi Miyamoto, MD principal investigator
Osaka Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incision technique in people with Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement, run by Zimmer Biomet at 1 site in Japan.
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: finished, as of the sponsor's last update on 27 Mar 2019. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Force from femoral and tibial side to retract and bring visual field into view (time frame: intraoperatively). 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 27 Mar 2019.