Osteoarthritis of the KneeNCT02543489
Flex Intramedullary Rod Study
A study testing Flex IM rod in people with Osteoarthritis of the Knee and Arthroplasty, Replacement, Knee, run by Stryker Japan K.K. at 3 sites in Japan.
Trial summary
The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis of the Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- Flex IM rod
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesJapan
- Study dates
- Dec 2012to Sep 2019
- 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 has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 20 years or older.
- Patient is candidate for primary Total Knee Arthroplasty (TKA).
- Patient whose preoperative range of motion (ROM) is over 110 degree.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- Revision cases
- Patients that use bone wedges or allograft due to bone loss.
- Patient has a Body Mass Index (BMI) >40.
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
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- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- Patient has failed unicondylar knee prosthesis.
- Patient has a known sensitivity to device materials.
- Patient who are inappropriate for participating in the study in the judgment of the investigator.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, 663-8501
Osaka General Medical Center
Osaka, 558-8558
Saiseikai Yokohama East Hospital
Yokohama, Kanagawa, 230-8765
About this study
Official title: A Prospective, Post-market, Multi-center Comparative Study of the Efficacy of Flex Intramedullary(IM) Rod in Terms of Range of Motion (ROM) Improvement.
The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod.
- Being tested
- Flex IM rod
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flex IM rodDevice
| Study group | Role | What they receive |
|---|---|---|
| Flex IM Rod | Other | Not described Receives: Device: Flex IM rod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum postoperative flexion angle
Measured: 48 weeks after surgery
Secondary outcomes (4)
Quality of life as assessed by36-Item Short-Form Health Survey (SF-36)questionnaire
Measured: 4 weeks , 24 weeks and 48 weeks after surgery
Japanese Knee Osteoarthritis Measure(JKOM)
Measured: 4 weeks , 24 weeks and 48 weeks after surgery
Knee Society Scale (KSS)
Measured: 4 weeks , 24 weeks and 48 weeks after surgery
Range of Motion (ROM)
Measured: 4 weeks , 24 weeks and 48 weeks after surgery
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 startDec 2012
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT02543489
- Sponsor's protocol ID
- SJCR-OR-1103
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2015
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-market, Multi-center Comparative Study of the Efficacy of Flex Intramedullary(IM) Rod in Terms of Range of Motion (ROM) Improvement.
- ClinicalTrials.gov ID
- NCT02543489
- Acronym / sponsor ID
- SJCR-OR-1103
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stryker Japan K.K.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- 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 post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flex IM Rod | Other | Device: Flex IM rod |
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 has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 20 years or older.
- Patient is candidate for primary Total Knee Arthroplasty (TKA).
- Patient whose preoperative range of motion (ROM) is over 110 degree.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (10 listed)
- Revision cases
- Patients that use bone wedges or allograft due to bone loss.
- Patient has a Body Mass Index (BMI) >40.
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- Patient has a neuromuscular or neurosensory deficiency, which limits the 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 |
|---|---|---|
| Flex IM rod | Device | Flex IM Rod |
Primary outcome
Maximum postoperative flexion angle
Time frame: 48 weeks after surgery
4 secondary outcomes
Quality of life as assessed by36-Item Short-Form Health Survey (SF-36)questionnaire
Time frame: 4 weeks , 24 weeks and 48 weeks after surgery
Japanese Knee Osteoarthritis Measure(JKOM)
Time frame: 4 weeks , 24 weeks and 48 weeks after surgery
Knee Society Scale (KSS)
Time frame: 4 weeks , 24 weeks and 48 weeks after surgery
Range of Motion (ROM)
Time frame: 4 weeks , 24 weeks and 48 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
Yasuyuki Inatsugu study director
Stryker Japan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flex IM rod in people with Osteoarthritis of the Knee and Arthroplasty, Replacement, Knee, run by Stryker Japan K.K. at 3 sites 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 10 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 14 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 3 sites 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?
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?
Maximum postoperative flexion angle (time frame: 48 weeks 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 14 Sep 2018.