Degenerative Joint DiseaseNCT02543463
Navigation With X3 vs Non-Navigation With X3 Study
A study testing Trident X3 Insert with Navigation system and Trident X3 Insert with conventional instrumentation in people with Degenerative Joint Disease, run by Stryker Japan K.K. at 1 site in Japan.
Trial summary
The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- Trident X3 Insert with Navigation system and Trident X3 Insert with conventional instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2015to 31 Jul 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
- Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
- Patient who is age 20 or over.
- Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
- Patient who is willing to and able to comply with postoperative scheduled evaluations.
Who cannot join
- Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
- Patient who requires revision surgery of a previously implanted total hip arthroplasty.
- Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
- Patient who is or may be pregnant female.
- Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
- Patient who is immunologically suppressed or receiving chronic steroids.
- Patient who is judged ineligible with specific reason by primary doctor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison X3 Study Between Navi-THA and Non-navi-THA
The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.
- Conditions
- Degenerative Joint Disease
- Being tested
- Trident X3 Insert with Navigation system, Trident X3 Insert with conventional instrumentation
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident X3 Insert with Navigation systemDevice
Trident X3 Insert with conventional instrumentationDevice
| Study group | Role | What they receive |
|---|---|---|
| With Navigation system | Other | Large diameter head with Trident X3 insert with Navigation system Receives: Device: Trident X3 Insert with Navigation system |
| Without Navigation system | Other | Large diameter head with Trident X3 insert with conventional instrumentation Receives: Device: Trident X3 Insert with conventional instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (ROM) during surgery
Measured: intraoperative
Secondary outcomes (3)
Measuring accuracy of the ROM during surgery
Measurement ROM precision of intraoperative
Measured: Intraoperative
implantation accuracy
Measurement of the degree of stem anteversion, cup anteversion and cup abduction
Measured: Intraoperative
Postoperative dislocation
Measured: From intraoperative to 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startApr 2015
- Primary completion31 Mar 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Japan K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasuyuki Inatsugu, Study director, Stryker Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543463
- Sponsor's protocol ID
- SJCR-OR-1101v2
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2015
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison X3 Study Between Navi-THA and Non-navi-THA
- ClinicalTrials.gov ID
- NCT02543463
- Acronym / sponsor ID
- SJCR-OR-1101v2
- Conditions
- Degenerative Joint Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Stryker Japan K.K.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 7 Sep 2015 (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 compare the effect of the large head in THA with a navigation system and without a navigation system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Navigation system | Other | Device: Trident X3 Insert with Navigation systemLarge diameter head with Trident X3 insert with Navigation system |
| Without Navigation system | Other | Device: Trident X3 Insert with conventional instrumentationLarge diameter head with Trident X3 insert with conventional instrumentation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
- Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
- Patient who is age 20 or over.
- Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
- Patient who is willing to and able to comply with postoperative scheduled evaluations.
Key exclusion criteria (8 listed)
- Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
- Patient who requires revision surgery of a previously implanted total hip arthroplasty.
- Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
- Patient who is or may be pregnant female.
- Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
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 |
|---|---|---|
| Trident X3 Insert with Navigation system | Device | With Navigation system |
| Trident X3 Insert with conventional instrumentation | Device | Without Navigation system |
Primary outcome
Range of motion (ROM) during surgery
Time frame: intraoperative
3 secondary outcomes
Measuring accuracy of the ROM during surgery
Time frame: Intraoperative
implantation accuracy
Time frame: Intraoperative
Postoperative dislocation
Time frame: From intraoperative to 1yr
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 29 Oct 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.
Yasuyuki Inatsugu study director
Stryker Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trident X3 Insert with Navigation system and Trident X3 Insert with conventional instrumentation in people with Degenerative Joint Disease, run by Stryker Japan K.K. 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 5 inclusion and 8 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 29 Oct 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 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?
Range of motion (ROM) during surgery (time frame: intraoperative). 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 29 Oct 2018.