Triathlon PKR Study in Japan

NCT02552095 | Completed

• 1 other identifier: SJCR-OR-1302
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Pre-operation, 6 months, 12 months and 24 months after surgery

Secondary Outcomes (3)

• 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

Study Arms (1)

Triathlon PKR

OTHER

Patient who receives the Triathlon.

Device: Triathlon PKR

Interventions

Triathlon PKR DEVICE

Triathlon PKR

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Japan K.K.: lead

Study Sites (5)

Kushiro-sanjikai Hospital

Kushiro, Hokkaido, 085-0836, Japan

Location

Akabane Central General Hospital

Tokyo, Kita-ku, 115-0044, Japan

Location

Toneyama National Hospital

Toyonaka, Osaka, 560-8552, Japan

Location

Nihon University Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Japanese Red Cross Kyoto Daiichi Hospital

Kyoto, 605-0981, Japan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: September 16, 2015
• Study Start: June 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

JP (5)