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Completed

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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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kushiro-sanjikai Hospital, Kushiro, Hokkaido, Japan

Loading trial locations.

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

Triathlon PKR

Device

Primary outcomes

  1. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Pre-operation, 6 months, 12 months and 24 months after surgery

Secondary outcomes

  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

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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