Clinical trial NCT02552095: Triathlon PKR Study in Japan
Official title: A Prospective, Single Arm, Multi Center Study on the Compatibility of Triathlon PKR and the Motion Analysis for Japanese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Stryker Japan K.K.
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patient requires a primary unicompartmental knee replacement.
2. Patient is between 20 years old to 80 years old.
3. Patient is diagnosed as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis.
4. Patient can walk independently at least 10m.
5. Patient has signed the Institutional Review Board (IRB) approved, study specific informed patient consent form.
6. Patient is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient requires a revision.
2. Patient is pregnant.
3. Patient has lateral osteoarthritis.
4. Patient has less than 10°of flexion contracture and greater than 90°of flexion.
5. Patient's preoperative mechanical alignment is less than 10° of varus and 15° of valgus.
6. Patient has had high tibial osteotomy, femoral osteotomy and/or joint fusion.
7. Patient has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
8. Patient has a systemic or metabolic disorder leading to progressive bone deterioration.
9. Patient is immunologically suppressed or receiving steroids (\>30 days) in excess of normal physiological requirements.
10. Patient has a deformity which will require the use of wedges or augments.
11. Patient has an active or suspected latent infection in or about the knee joint.
12. Patient who is inappropriate for participating in the study by the judgment of the investigator.

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre-operation, 6 months, 12 months and 24 months after surgery
Secondary outcomes:
measure: Measurement of tibial resection plane (A-P length and width of resection)
timeFrame: intraoperative
measure: Change in Quality of life as assessed by 12-Item Short-Form Health Survey (SF-12) questionnaire
timeFrame: Pre-operation, 6 months, 12 months and 24 months after surgery
measure: Change in Japanese Orthopaedics Association (JOA) score
timeFrame: Pre-operation, 6 months, 12 months and 24 months after surgery
Other outcomes:
Locations:
city: Kushiro
country: Japan
facility: Kushiro-sanjikai Hospital
state: Hokkaido
city: Tokyo
country: Japan
facility: Akabane Central General Hospital
state: Kita-ku
city: Toyonaka City
country: Japan
facility: Toneyama National Hospital
state: Osaka
city: Itabashi-ku
country: Japan
facility: Nihon University Hospital
state: Tokyo
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hospital
Study officials:
References: