A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System

NCT ID: NCT03289000

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-24

Study Completion Date

2017-12-31

Brief Summary

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This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.

Detailed Description

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Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.

* Demographics and Medical History
* Pre \& Post-Operative Data including Range of Motion
* Surgical Data
* Survivorship (phone/email or last known visit)
* Patient Reported Outcomes (phone/email single time point visit)

* Patient Satisfaction
* KOOS Jr.

Conditions

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Osteo Arthritis Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ConforMIS PS Group

Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System

iTotal Posterior Stabilized (PS) Knee Replacement System

Intervention Type DEVICE

Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs

Interventions

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iTotal Posterior Stabilized (PS) Knee Replacement System

Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
2. Over 18 Years of age

Exclusion Criteria

1\. BMI \> 40
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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Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States

Site Status

Scott Orthopedic Center

Huntington, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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16-004

Identifier Type: -

Identifier Source: org_study_id

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