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A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf

NCT02251522 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 873

Last updated 2023-10-25

No results posted yet for this study

Summary

It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.

Conditions

Interventions

DEVICE

ConforMIS Total Knee Replacement System

Total knee replacement system using a patient specific implant.

DEVICE

Off-the-Shelf Knee Replacement System

Total knee replacement system not using a patient specific implant.

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Principal Investigators

  • Robert Tait, MD · Orthopaedic Institute of Henderson

  • Mary O'Connor, MD · Yale University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-10-31
Completion
2016-12-31
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251522 on ClinicalTrials.gov