Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement

NCT ID: NCT01505452

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of this study is to clinically demonstrate a phenomenon of measurement error that can occur during placement of a specific type of total knee replacement prosthesis (single radius femoral component) using a certain type of surgical technique (flexion/extension gap balancing).

Conditions

Arthritis of Knee

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Scheduled to undergo primary total knee arthroplasty performed by the principal investigator
• Use of a single radius posterior-stabilized TKA prosthesis is planned
• Spinal anesthetic is planned
• Diagnosis of osteoarthritis
• Has normal knee ligaments with no history of previous injury or surgery to ligaments, or other pathologic condition
• Has at least 100 degrees knee flexion preoperatively (measured by long goniometer)
• Gives valid informed consent
• Age 18 years or older

Exclusion Criteria

• Patient receives general anesthetic
• Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, avascular necrosis, post-traumatic arthritis)
• History of any prior knee ligament injury, or any surgery to ligaments
• Any connective tissue disease affecting integrity of the ligaments (must have normal ligaments)
• History of long bone fracture in the affected leg
• Flexion contracture that would interfere with ability to establish extension gap reliably (judgment of investigator)
• Maximum pre-operative knee flexion is less than 100 degrees.
• Patient is non-ambulatory
• Any preclusion or inability to use navigation
• Treatment with single radius posterior stabilized TKA prosthesis is not indicated
• Participation is not in best interest of patient for any reason
• Cannot or does not give valid informed consent
• Female patient who is currently pregnant
• Age less than 18 years
• Body mass index greater than 40 kg/(m*m)
• Incarcerated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Athens Orthopedic Clinic, P.A.

OTHER

Sponsor Role: lead

Responsible Party

Ormonde M. Mahoney, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ormonde M Mahoney, MD

Role: PRINCIPAL_INVESTIGATOR

Athens Orthopedic Clinic

Locations

Athens Orthopedic Clinic

Athens, Georgia, United States

St Mary's Hospital

Athens, Georgia, United States

Countries

United States

Other Identifiers

AOC-OM-Stryker-2009-0019

Identifier Type: -

Identifier Source: org_study_id