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Completed

NCT Number: NCT00279838

Computer Assisted Total Knee Replacement

The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

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Key information

Conditions

Total Knee Arthroplasty Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation.

Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Study participants must:

  • Be over 18 years of age.
  • Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol.
  • The subject has given consent to the transfer of his/her information to the sponsor.

Treatment and study plan

Computer Assisted Navigation Knee Replacement

Procedure

Primary outcomes

  1. To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation

Secondary outcomes

  1. To compare the frontal alignment of the femoral and tibial components from full length standing radiographs

  2. To compare sagittal alignment of the femoral and tibial components from lateral radiographs

  3. To compare the rotation of the femoral and tibial components from CT Scan.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • DePuy Orthopaedics

Registry information

Official study title

Computer Assisted Navigation in Total Knee Arthroplasty

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 20, 2006
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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