Comparison of In Vivo Alignment With TruMatchâ„¢ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKA)
Summary
This investigation is intended to provide clinical information about alignment using TruMatchâ„¢ and to compare the results to a conventional total knee replacement. TruMatchâ„¢ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques.
The purpose of this investigation is to determine whether TruMatchâ„¢ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same IRR as the historical control study.
Description
The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatchâ„¢ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.
Each enrolled Subject will undergo a total knee replacement using the TruMatchâ„¢ surgical technique. This investigation will require the Subject to be followed once postoperatively to collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the Subject can achieve full leg extension (=/-5 degrees) and can tolerate weight-bearing.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Osteoarthritis, Knee
Intervention
TruMatchâ„¢ Personalized Solutions
Location
Towson Orthopaedic Associates
Baltimore
Maryland
United States
21204
Status
Recruiting
Source
DePuy Orthopaedics
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01108237
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
Viscosupplements
Viscoelastic solutions that are injected into JOINTS in order to alleviate symptoms of joint-related disorders such as OSTEOARTHRITIS.
Ophthalmic Solutions
Sterile solutions, essentially free from foreign particles and suitably compounded and dispensed, for instillation into the eye. It does not include solutions for cleaning eyeglasses or CONTACT LENS SOLUTIONS. (From Dorland, 27th ed)
Knee Injuries
Injuries to the knee or the knee joint.
Knee Prosthesis
Replacement for a knee joint.
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