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Comparison of In Vivo Alignment With TruMatchâ„¢ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKA)

09:09 EDT 18th April 2014 | BioPortfolio

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)

View Results

Links

Medical and Biotech [MESH] Definitions

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)

Viscoelastic solutions that are injected into JOINTS in order to alleviate symptoms of joint-related disorders such as OSTEOARTHRITIS.

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)

Injuries to the knee or the knee joint.

Replacement for a knee joint.

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