NCT Number: NCT02552095
Triathlon PKR Study in Japan
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.
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Notify MeKey information
Conditions
Age range
20 year–79 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Kushiro-sanjikai Hospital, Kushiro, Hokkaido, Japan
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Treatment and study plan
Primary outcomes
-
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Pre-operation, 6 months, 12 months and 24 months after surgery
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
Sponsors and collaborators
Lead sponsor
Stryker Japan K.K.
Industry
Registry information
Official study title
A Prospective, Single Arm, Multi Center Study on the Compatibility of Triathlon PKR and the Motion Analysis for Japanese
Important dates
- Study start
- 2013
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Sep 16, 2015
- Registry last updated
- Sep 14, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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