NCT00409266

Brief Summary

The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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withdrawn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

First Submitted

Initial submission to the registry

December 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

December 6, 2006

Last Update Submit

November 2, 2021

Conditions

Total Knee Arthroplasty

Study Arms (1)

Functional flexion axis of the knee

OTHER

The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.

Device: Computer assisted navigation

Interventions

Computer assisted navigationDEVICE
Functional flexion axis of the knee

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and Females over the age of 18 and equal to or less than the age of 60
  • Patients scheduled for elective Total knee arthroplasty surgery
  • Patients who have signed informed consent and HIPAA Authorization
  • Able to speak and understand English

You may not qualify if:

  • Patients presenting with evidence of recent trauma, active infection, chronic pain syndrome of the spine, dementia or have been diagnosed with Alzheimer's disease
  • Pregnant women
  • Patients that will not sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan Hospital

Plymouth, Massachusetts, 02360, United States

Location

Related Publications (1)

  • Stoeckl B, Nogler M, Krismer M, Beimel C, de la Barrera JL, Kessler O. Reliability of the transepicondylar axis as an anatomical landmark in total knee arthroplasty. J Arthroplasty. 2006 Sep;21(6):878-82. doi: 10.1016/j.arth.2005.10.020.

    PMID: 16950043BACKGROUND

Study Officials

  • R S Oliver, M.D.

    Jordan Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 8, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

November 10, 2021

Record last verified: 2021-11

Locations

US(1)