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OpenTrials
Completed

NCT Number: NCT03289000

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

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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tennessee Orthopaedic Alliance, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • BMI > 40

Treatment and study plan

iTotal Posterior Stabilized (PS) Knee Replacement System

Device

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

Primary outcomes

  1. Demographics and Medical History

    Time frame: 1 year

    Demographics and medical history gathered from medical records

  2. Pre and Post Operative Range of Motion

    Time frame: 1 year

    Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2017
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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