NCT02257099

Brief Summary

The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan.

Trial Health

87
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 Feb 2015

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

September 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 29, 2014

Results QC Date

April 14, 2016

Last Update Submit

September 12, 2019

Conditions

Patellar (or Kneecap) Instability and Mal-alignment

Outcome Measures

Primary Outcomes (1)

  • Congruence Angle CBCT

    Baseline

Secondary Outcomes (2)

  • Tilt Angle

    Baseline

  • Tibial Tuberosity Trochlear Groove

    Baseline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with acute or chronic patellar malalignment.

You may qualify if:

  • Patients who have been diagnosed with acute or chronic patellar malalignment.
  • At least 16 years old
  • Be willing and able to provide informed consent

You may not qualify if:

  • Open growth plates
  • Previous knee surgery on the affected knee
  • Pregnancy (females)
  • Fracture of the patellofemoral joint
  • Knee ligament injury (other than medial patellofemoral ligament)
  • Have greater than Grade II degenerative changes of the patellofemoral joint
  • Inability to bear weight on the extremity during the CT scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UBMD Orthopaedics and Sports Medicine, Northtowns office

Amherst, New York, 14226, United States

Location

UBMD Orthopaedics and Sports Medicine, Southtowns Office

Orchard Park, New York, 14127, United States

Location

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and Injuries

Results Point of Contact

Title
John Marzo, MD
Organization
UBMD Orthopaedics and Sports Medicine
jmmarzo@buffalo.edu
7168292982

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Orthopaedics

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 6, 2014

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

October 3, 2019

Results First Posted

October 3, 2019

Record last verified: 2019-09

Locations

US(2)