Triathlon PKR Study in Japan

NCT ID: NCT02552095

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-09-30

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon PKR

Patient who receives the Triathlon.

Group Type: OTHER

Triathlon PKR

Intervention Type: DEVICE

Interventions

Triathlon PKR

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Japan K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kushiro-sanjikai Hospital

Kushiro, Hokkaido, Japan

Akabane Central General Hospital

Tokyo, Kita-ku, Japan

Toneyama National Hospital

Toyonaka, Osaka, Japan

Nihon University Hospital

Itabashi-ku, Tokyo, Japan

Japanese Red Cross Kyoto Daiichi Hospital

Kyoto, , Japan

Countries

Japan

Other Identifiers

SJCR-OR-1302

Identifier Type: -

Identifier Source: org_study_id