A Retrospective Study of the iTotal CR Knee Replacement System

NCT ID: NCT01564654

Last Updated: 2023-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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iTotal KRS

iTotal KRS

Intervention Type DEVICE

Total Knee Replacement System

Interventions

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iTotal KRS

Total Knee Replacement System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Clinical condition included in the approved Indications For Use
2. Has signed the informed consent form to allow review of medical records and collection of data therein.
3. \> 18 years of age

Exclusion Criteria

1. Treatment with iTotal in a manner inconsistent with Instructions for Use
2. Unwilling to sign then informed consent form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Restor3D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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STAR Orthopedics

La Quinta, California, United States

Site Status

Preferred Orthopedics of the Palm Beaches

Boynton Beach, Florida, United States

Site Status

Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States

Site Status

Central Utah Clinic

Provo, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CCP 11-002

Identifier Type: -

Identifier Source: org_study_id

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