NCT01367938CompletedNot Applicable
OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study
Spokane Joint Replacement Center1 site in 1 country69 target enrollmentStarted: November 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Clinical outcomes
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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) >
- •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.
Outcomes
Primary Outcomes
Clinical outcomes
Time Frame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Clinical outcomes to include overall success, revision rate, adverse events, clinical score (Knee Society Score), range of motion, radiographic findings.
Secondary Outcomes
No secondary outcomes reported
Investigators
David F. Scott, MD
PI
Spokane Joint Replacement Center
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Unknown
Bi unicondylar knee arthroplasty versus Total knee arthroplasty: A Randomized Clinical TrialKnee osteoarthritis - knee joint replacement.Unilateral primary osteoarthritis, unspecified kneeM17.10IRCT20230926059523N1Shahid Beheshti University of Medical Sciences26
Active, not recruiting
Not Applicable
Finnish Unicompartmental and Total Knee Arthroplasty InvestigationOsteoarthritis, KneeNCT02481427Turku University Hospital140
Completed
Not Applicable
Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients with Anteromedial Osteoarthritis of the KneeOsteoarthritisNCT02430129Alberta Hip and Knee Clinic38
Completed
Not Applicable
Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee ArthroplastyPost Operative PainNCT05510947Copenhagen University Hospital, Hvidovre146
Active, not recruiting
Not Applicable
Multicentre GMK UNI Anatomical Cementless Study - FROsteoarthritis of the KneeAvascular Necrosis of the Femoral CondyleRevision SurgeryNCT06715917Medacta International SA249