Triathlon PKR Study in Japan

A Prospective, Single Arm, Multi Center Study on the Compatibility of Triathlon PKR and the Motion Analysis for Japanese

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Device: Triathlon PKR

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Triathlon PKR; Patient who receives the Triathlon.	Device: Triathlon PKR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)	Pre-operation, 6 months, 12 months and 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of tibial resection plane (A-P length and width of resection)	intraoperative
Change in Quality of life as assessed by 12-Item Short-Form Health Survey (SF-12) questionnaire	Pre-operation, 6 months, 12 months and 24 months after surgery
Change in Japanese Orthopaedics Association (JOA) score	Pre-operation, 6 months, 12 months and 24 months after surgery

Collaborators and Investigators

• Sponsor: Stryker Japan K.K.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SJCR-OR-1302