Clinical Outcomes With Omni Apex Ultracongruent Knee System

NCT01367938 | Completed DMC

• 1 other identifier: SJRC-OK
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Total Knee Replacement; Total Knee Arthroplasty; TKA; Knee

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

OMNI Apex Ultracongruent Knee Device

Device: OMNI Apex Ultracongruent Knee Device

Interventions

OMNI Apex Ultracongruent Knee Device DEVICE

OMNI Apex Ultracongruent Knee Device

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing total knee replacement

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spokane Joint Replacement Center: lead

Study Sites (1)

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David F Scott, MD

  Spokane Joint Replacement Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 22, 2011
• First Posted: June 7, 2011
• Study Start: November 1, 2009
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

US (1)