Triathlon PKR Study in Japan

Not Applicable

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Device: Triathlon PKR

• Registration Number: NCT02552095
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Status Verified: 2018-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triathlon PKR	Triathlon PKR	Patient who receives the Triathlon.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Measurement of tibial resection plane (A-P length and width of resection)	intraoperative
Change in Japanese Orthopaedics Association (JOA) score	Pre-operation, 6 months, 12 months and 24 months after surgery

Trial Locations

Locations (5)

Japanese Red Cross Kyoto Daiichi Hospital; 🇯🇵 Kyoto, Japan

Nihon University Hospital; 🇯🇵 Itabashi-ku, Tokyo, Japan

Akabane Central General Hospital; 🇯🇵 Tokyo, Kita-ku, Japan

Kushiro-sanjikai Hospital; 🇯🇵 Kushiro, Hokkaido, Japan

Toneyama National Hospital; 🇯🇵 Toyonaka City, Osaka, Japan