Clinical Outcomes With Omni Apex Ultracongruent Knee System

Osteoarthritis, Knee Clinical Trial

Official title:

OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367938
• Other study ID #: SJRC-OK
• Status: Completed
• Start date: November 2009
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Spokane Joint Replacement Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective, matched case comparison of total knee arthroplasty with the OMNI Apex Ultracongruent vs. Triathlon® CS tibial insert vs. the Triathlon® PS tibial insert.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients willing to sign the informed consent.

• Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations.

• Male and non-pregnant female patients ages 21-80 years of age at time of surgery.

• Patients requiring a primary total knee replacement.

• Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).

• Patients with intact collateral ligaments.

Exclusion Criteria:

• Patients with inflammatory arthritis.

• Patients that are morbidly obese, body mass index (BMI) > 40.

• Patients with a history of total or unicompartmental reconstruction of the affected joint.

• Patients that have had a high tibial osteotomy or femoral osteotomy.

• Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.

• Patients with a systemic or metabolic disorder leading to progressive bone deterioration.

• Patients that are immunologically compromised, or receiving chronic steroids (>30 days).

• Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.

• Patients with knee fusion to the affected joint.

• Patients with an active or suspected latent infection in or about the knee joint.

• Patients that computer-assisted surgical navigation (CAOS) techniques will be used.

• Patients that minimally invasive surgical technique will be used.

• Patients that are prisoners.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• OMNI Apex Ultracongruent Knee Device

Locations

Country	Name	City	State
United States	Spokane Joint Replacement Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Spokane Joint Replacement Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes	Clinical outcomes to include overall success, revision rate, adverse events, clinical score (Knee Society Score), range of motion, radiographic findings.	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative