Triathlon PKR Study in Japan
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Triathlon PKR
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility Criteria
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.
Sites / Locations
- Kushiro-sanjikai Hospital
- Akabane Central General Hospital
- Toneyama National Hospital
- Nihon University Hospital
- Japanese Red Cross Kyoto Daiichi Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Triathlon PKR
Arm Description
Patient who receives the Triathlon.
Outcomes
Primary Outcome Measures
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Secondary Outcome Measures
Measurement of tibial resection plane (A-P length and width of resection)
Change in Quality of life as assessed by 12-Item Short-Form Health Survey (SF-12) questionnaire
Change in Japanese Orthopaedics Association (JOA) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02552095
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Japan K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triathlon PKR
Arm Type
Other
Arm Description
Patient who receives the Triathlon.
Intervention Type
Device
Intervention Name(s)
Triathlon PKR
Primary Outcome Measure Information:
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
Pre-operation, 6 months, 12 months and 24 months after surgery
Secondary Outcome Measure Information:
Title
Measurement of tibial resection plane (A-P length and width of resection)
Time Frame
intraoperative
Title
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
Title
Change in Japanese Orthopaedics Association (JOA) score
Time Frame
Pre-operation, 6 months, 12 months and 24 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kushiro-sanjikai Hospital
City
Kushiro
State/Province
Hokkaido
ZIP/Postal Code
085-0836
Country
Japan
Facility Name
Akabane Central General Hospital
City
Tokyo
State/Province
Kita-ku
ZIP/Postal Code
115-0044
Country
Japan
Facility Name
Toneyama National Hospital
City
Toyonaka City
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Nihon University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daiichi Hospital
City
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
12. IPD Sharing Statement
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Triathlon PKR Study in Japan
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