Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
Stopped early · Not applicable
Conditions studied: Degenerative Arthritis of Knee
In brief
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.
Key facts
- Study ID
- NCT01084772
- Run by
- Smith & Nephew, Inc.
- People needed
- 134
- Starts
- 2012-06-21
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2020-04-03
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must meet all of the inclusion criteria.
- Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA.
- Patient is of legal age to consent and is skeletally mature.
- Patient is willing to sign and date an ethics-approved consent form.
- Patient is willing to be available for two-year follow-up postoperatively
You may not qualify if…
- Patients must not meet any of the exclusion criteria.
- Patient is known to have poor bone stock making a TKA unjustifiable.
- Patient is immuno-suppressed.
- Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- Patient is pregnant or may become pregnant during the course of the study.
- Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty, high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as ACL repair, meniscectomy, or arthroscopy are not excluded.
- Patient has active, localized or systemic infection.
- Patient is severely overweight (BMI >40).
- Patient is a prisoner.
- Subject has a significant MRI (magnetic resonance imaging) exclusion or contraindication.
- Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.
Where it is running
- Orthopaedic Surgery Specialist, Ltd. — Park Ridge, Illinois, United States
- Southern Illinois University School of Medicine — Springfield, Illinois, United States
- Town & Country Orthopedics — St Louis, Missouri, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
- Slocum Research & Education Foundation — Eugene, Oregon, United States
- Malabar Orthopaedic Clinic — Windsor, Victoria, Australia
Full record on ClinicalTrials.gov
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