Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01564654
NCT01564654
Completed
Not Applicable

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

Restor3D4 sites in 1 country89 target enrollmentJanuary 2012
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Restor3D
Enrollment
89
Locations
4
Primary Endpoint
Knee Function
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
January 2013
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Restor3D
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Knee Function

Time Frame: Average of 7 months post-operative

Range of Motion

Secondary Outcomes

  • Number of Transfusions(Initial hospital stay)
  • Manipulations Under Anesthesia(Up to 7 months post-operative)
  • Revision Rate(Average of 7 months)

Study Sites (4)

Loading locations...

Similar Trials

Completed
Not Applicable
Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)Prostatic Neoplasms
NCT02443571Blue Earth Diagnostics714
Completed
Not Applicable
Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia RepairHernia, InguinalHernia, Inguinal, DirectHernia, Inguinal, Indirect
NCT02684448Intuitive Surgical1,258
Completed
Not Applicable
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin CancersSkin Cancer
NCT06463860MetaOptima Technology Inc.81
Terminated
Not Applicable
Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic NailFractures, Bone
NCT06412913Orthofix s.r.l.6
Terminated
Not Applicable
Retrospective Study on Clinical Performance and Safety Profile of Agile NailFractures, BoneImpending FractureDeformity; Bone
NCT06412939Orthofix s.r.l.20