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Trial record 19 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Triathlon PKR Study in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02552095
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Japan K.K.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Device: Triathlon PKR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single Arm, Multi Center Study on the Compatibility of Triathlon PKR and the Motion Analysis for Japanese
Study Start Date : June 2013
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Triathlon PKR
Patient who receives the Triathlon.
Device: Triathlon PKR



Primary Outcome Measures :
  1. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Pre-operation, 6 months, 12 months and 24 months after surgery ]

Secondary Outcome Measures :
  1. Measurement of tibial resection plane (A-P length and width of resection) [ Time Frame: intraoperative ]
  2. 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 ]
  3. Change in Japanese Orthopaedics Association (JOA) score [ Time Frame: Pre-operation, 6 months, 12 months and 24 months after surgery ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552095


Locations
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Japan
Kushiro-sanjikai Hospital
Kushiro, Hokkaido, Japan, 085-0836
Akabane Central General Hospital
Tokyo, Kita-ku, Japan, 115-0044
Toneyama National Hospital
Toyonaka City, Osaka, Japan, 560-8552
Nihon University Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Japan, 605-0981
Sponsors and Collaborators
Stryker Japan K.K.

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Responsible Party: Stryker Japan K.K.
ClinicalTrials.gov Identifier: NCT02552095     History of Changes
Other Study ID Numbers: SJCR-OR-1302
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases