Triathlon PKR Study in Japan

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552095
• Other study ID #: SJCR-OR-1302
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: Stryker Japan K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Triathlon PKR

Locations

Country	Name	City	State
Japan	Nihon University Hospital	Itabashi-ku	Tokyo
Japan	Kushiro-sanjikai Hospital	Kushiro	Hokkaido
Japan	Japanese Red Cross Kyoto Daiichi Hospital	Kyoto
Japan	Akabane Central General Hospital	Tokyo	Kita-ku
Japan	Toneyama National Hospital	Toyonaka City	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)		Pre-operation, 6 months, 12 months and 24 months after surgery
Secondary	Measurement of tibial resection plane (A-P length and width of resection)		intraoperative
Secondary	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
Secondary	Change in Japanese Orthopaedics Association (JOA) score		Pre-operation, 6 months, 12 months and 24 months after surgery