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Balanced Knee System Clinical Protocol for IRB Approval

NCT02362867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-09-24

No results posted yet for this study

Summary

The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.

Conditions

  • Osteoarthritis, Knee
  • Rheumatoid Arthritis of Knee
  • Post-traumatic Osteoarthritis of Knee Nos
  • Valgus Deformity

Interventions

DEVICE

Balanced Knee System

A multi-compartmental total knee replacement providing a system of components for primary posterior cruciate ligament substituting procedures. The system consists of femoral, tibial, and patellar components that allow the surgeon to select the most appropriate component combination to meet specific patient needs.

Sponsors & Collaborators

  • St. Mark's Hospital

    collaborator UNKNOWN

  • Salt Lake Orthopaedic Clinic

    collaborator UNKNOWN

  • Ortho Development Corporation

    lead INDUSTRY

Principal Investigators

  • Michael H. Bourne, M.D. · Salt Lake Orthopaedic Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2019-06-02
Completion
2019-06-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02362867 on ClinicalTrials.gov