NCT02762630

Brief Summary

Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess normal alignment of the knee joint

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

May 3, 2016

Last Update Submit

April 26, 2017

Conditions

Patellofemoral Joint

Outcome Measures

Primary Outcomes (1)

  • Tibial tubercle-trochlear groove (TT-TG) offset distance (mm)

    1 day

Interventions

Carestream Health Inc. weight bearing cone beam CT scannerDEVICE

Eligibility Criteria

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

Healthy volunteers

You may qualify if:

  • Willing and able to provide written informed consent
  • Be 16 or more years of age
  • Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion during the images

You may not qualify if:

  • Have a history of patella instability
  • Have had any type of previous knee surgery
  • Have had a significant fracture of the patellofemoral joint
  • Have a knee ligament injury
  • Are pregnant at the time of screening or become pregnant during the study
  • Have a history of high radiation exposure (i.e., undergone radiation therapy)
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Orthopedics

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04