Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee (TriathlonCR)

Stryker

Status: Completed

Conditions: Total Knee Arthroplasty

Treatments: Device: Triathlon CR Total Knee System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02535741

K-S-016

Details and patient eligibility

About

An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.

Full description

An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.

Enrollment: 168 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
2. Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
3. Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery.
4. Patients requiring a primary total knee replacement.
5. Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
6. Patients with intact collateral ligaments.

Exclusion criteria

1. Patients with inflammatory arthritis.
2. Patients that are morbidly obese, body mass index (BMI) > 40.
3. Patients with a history of total / unicompartmental reconstruction of the affected joint.
4. Patients that have had a high tibial osteotomy or femoral osteotomy.
5. Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
6. Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
7. Patients that are immunologically compromised, or receiving chronic steroids (>30 days duration).
8. Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
9. Patients with a knee fusion to the affected joint.
10. Patients with an active or suspected latent infection in or about the knee joint.
11. Patients with a history of total joint replacement on the opposite knee within less than 1 year.
12. Patients requiring bilateral total knee replacement.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Triathlon CR Total Knee System

Other group

Description:

Primary total knee replacement

Treatment:

Device: Triathlon CR Total Knee System