Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

Stryker

Status: Completed

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: Triathlon® CR Total Knee System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957723

56

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

Full description

The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.

Enrollment: 419 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject is a male or non-pregnant female between the ages of 21 and 80.
2. The subject requires a primary cemented total knee replacement.
3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
4. The subject has intact collateral ligaments.
5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form.
6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

1. Patient has inflammatory arthritis.
2. The subject is morbidly obese, BMI > 40.
3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
4. Patient has had a high tibial osteotomy or femoral osteotomy.
5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
7. The subject is immunologically suppressed, or receiving chronic steroids (> 30 days duration).
8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis.
9. The subject has had a knee fusion to the affected joint.
10. The subject has an active or suspected latent infection in or about the knee joint.
11. The subject is a prisoner.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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419 participants in 1 patient group

Triathlon® CR Total Knee System

Other group

Description:

Participants receive the Triathlon® CR Total Knee System

Treatment:

Device: Triathlon® CR Total Knee System