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OpenTrials
Completed

NCT Number: NCT01564654

A Retrospective Study of the iTotal CR Knee Replacement System

This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

STAR Orthopedics, La Quinta, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical condition included in the approved Indications For Use
  • Has signed the informed consent form to allow review of medical records and collection of data therein.
  • > 18 years of age

Exclusion criteria

  • Treatment with iTotal in a manner inconsistent with Instructions for Use
  • Unwilling to sign then informed consent form

Treatment and study plan

iTotal KRS

Device

Total Knee Replacement System

Primary outcomes

  1. Knee Function

    Time frame: Average of 7 months post-operative

    Range of Motion

Secondary outcomes

  1. Revision Rate

    Time frame: Average of 7 months

    Number of knees that required a reoperation to remove/replace/add implant components

  2. Number of Transfusions

    Time frame: Initial hospital stay

    Number of knees that required a blood transfusion during the initial hospital stay post-operative

  3. Manipulations Under Anesthesia

    Time frame: Up to 7 months post-operative

    Number of knees that required a subsequent procedure to restore knee range of motion

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Official study title

A Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2012
Registry last updated
Oct 25, 2023

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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