NCT00160797

Brief Summary

The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_4

Status
withdrawn

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

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

September 8, 2005

Last Update Submit

April 30, 2012

Conditions

Total Knee Replacement

Interventions

MIS™ Minimally Invasive Solutions™ TKA SystemDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of a severely disabled joint secondary to painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis that warrants primary knee arthroplasty.
  • Gender - Males and females will be included. The male-to-female ratio will depend upon the patient population at each institution conducting the study.
  • Age - Minimum of 18 years-old.
  • Stable Health - The patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
  • Patient or patient's legal representative has read and signed the Letter to the Patient form.

You may not qualify if:

  • Patient is skeletally immature.
  • Previous ipsilateral knee arthroplasty.
  • Previous Patellectomy.
  • Patient is pregnant or breastfeeding.
  • Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic, respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
  • Patients who have received an investigational drug or device within the last 30 days.
  • Patient is unwilling or unable to cooperate in a follow-up program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Richard G. Vlasak, M.D.

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

May 2, 2012

Record last verified: 2012-04