Osteoarthritis of the KneeNCT02552095
Triathlon PKR Study in Japan
A study testing Triathlon PKR in people with Osteoarthritis of the Knee, run by Stryker Japan K.K. at 5 sites in Japan.
Trial summary
The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee Replacement (PKR) with the Japanese population. It is expected that patients who receive the Triathlon PKR will achieve excellent clinical results without adverse effects and that the device fits well with Japanese morphology. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Triathlon PKR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 5 sitesJapan
- Study dates
- Jun 2013to Sep 2018
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires a primary unicompartmental knee replacement.
- Patient is between 20 years old to 80 years old.
- Patient is diagnosed as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis.
- Patient can walk independently at least 10m.
- Patient has signed the Institutional Review Board (IRB) approved, study specific informed patient consent form.
- Patient is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- Patient requires a revision.
- Patient is pregnant.
- Patient has lateral osteoarthritis.
- Patient has less than 10°of flexion contracture and greater than 90°of flexion.
- Patient's preoperative mechanical alignment is less than 10° of varus and 15° of valgus.
- Patient has had high tibial osteotomy, femoral osteotomy and/or joint fusion.
Show all 12Show fewer
- Patient has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
- Patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- Patient is immunologically suppressed or receiving steroids (>30 days) in excess of normal physiological requirements.
- Patient has a deformity which will require the use of wedges or augments.
- Patient has an active or suspected latent infection in or about the knee joint.
- Patient who is inappropriate for participating in the study by the judgment of the investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Nihon University Hospital
Itabashi-ku, Tokyo, 173-8610
Kushiro-sanjikai Hospital
Kushiro, Hokkaido, 085-0836
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, 605-0981
Akabane Central General Hospital
Tokyo, Kita-ku, 115-0044
Toneyama National Hospital
Toyonaka, Osaka, 560-8552
About this study
Official title: A Prospective, Single Arm, Multi Center Study on the Compatibility of Triathlon PKR and the Motion Analysis for Japanese
The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee Replacement (PKR) with the Japanese population. It is expected that patients who receive the Triathlon PKR will achieve excellent clinical results without adverse effects and that the device fits well with Japanese morphology.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Triathlon PKR
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon PKRDevice
| Study group | Role | What they receive |
|---|---|---|
| Triathlon PKR | Other | Patient who receives the Triathlon. Receives: Device: Triathlon PKR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Pre-operation, 6 months, 12 months and 24 months after surgery
Secondary outcomes (3)
Measurement of tibial resection plane (A-P length and width of resection)
Measured: intraoperative
Change in Quality of life as assessed by 12-Item Short-Form Health Survey (SF-12) questionnaire
Measured: Pre-operation, 6 months, 12 months and 24 months after surgery
Change in Japanese Orthopaedics Association (JOA) score
Measured: Pre-operation, 6 months, 12 months and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJun 2013
- Primary completionSep 2018
- Study completionSep 2018
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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Japan K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552095
- Sponsor's protocol ID
- SJCR-OR-1302
- 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, Single Arm, Multi Center Study on the Compatibility of Triathlon PKR and the Motion Analysis for Japanese
- ClinicalTrials.gov ID
- NCT02552095
- Acronym / sponsor ID
- SJCR-OR-1302
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Stryker Japan K.K.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 16 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 evaluate compatibility of the Triathlon Partial Knee Replacement (PKR) with the Japanese population. It is expected that patients who receive the Triathlon PKR will achieve excellent clinical results without adverse effects and that the device fits well with Japanese morphology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triathlon PKR | Other | Device: Triathlon PKRPatient who receives the Triathlon. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient requires a primary unicompartmental knee replacement.
- Patient is between 20 years old to 80 years old.
- Patient is diagnosed as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis.
- Patient can walk independently at least 10m.
- Patient has signed the Institutional Review Board (IRB) approved, study specific informed patient consent form.
Key exclusion criteria (12 listed)
- Patient requires a revision.
- Patient is pregnant.
- Patient has lateral osteoarthritis.
- Patient has less than 10°of flexion contracture and greater than 90°of flexion.
- Patient's preoperative mechanical alignment is less than 10° of varus and 15° of valgus.
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 |
|---|---|---|
| Triathlon PKR | Device | Triathlon PKR |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Pre-operation, 6 months, 12 months and 24 months after surgery
3 secondary outcomes
Measurement of tibial resection plane (A-P length and width of resection)
Time frame: intraoperative
Change in Quality of life as assessed by 12-Item Short-Form Health Survey (SF-12) questionnaire
Time frame: Pre-operation, 6 months, 12 months and 24 months after surgery
Change in Japanese Orthopaedics Association (JOA) score
Time frame: Pre-operation, 6 months, 12 months and 24 months after surgery
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 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon PKR in people with Osteoarthritis of the Knee, run by Stryker Japan K.K. at 5 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 6 inclusion and 12 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 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 5 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?
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?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Pre-operation, 6 months, 12 months and 24 months 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.