NCT01564654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2021

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

March 26, 2012

Results QC Date

July 13, 2017

Last Update Submit

October 23, 2023

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Knee Function

    Range of Motion

    Average of 7 months post-operative

Secondary Outcomes (3)

  • Revision Rate

    Average of 7 months

  • Number of Transfusions

    Initial hospital stay

  • Manipulations Under Anesthesia

    Up to 7 months post-operative

Study Arms (1)

iTotal KRS

Device: iTotal KRS

Interventions

iTotal KRSDEVICE

Total Knee Replacement System

iTotal KRS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have received an iTotal Knee replacement

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with iTotal in a manner inconsistent with Instructions for Use
  • Unwilling to sign then informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

STAR Orthopedics

La Quinta, California, 92253, United States

Location

Preferred Orthopedics of the Palm Beaches

Boynton Beach, Florida, 33437, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37203, United States

Location

Central Utah Clinic

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Marc Quartulli, VP Clinical Affairs
Organization
ConforMIS
marc.quartulli@conformis.com
781-345-9191

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 25, 2023

Results First Posted

January 20, 2021

Record last verified: 2023-10

Locations

US(4)