NCT01405729

Brief Summary

The purpose of this retrospective study was to determine the accuracy of femoral tunnel placement utilizing Redfern et al's radiographic method for anatomic femoral attachment during MPFL reconstruction in addition to the resultant outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

May 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

3.6 years

First QC Date

July 27, 2011

Last Update Submit

February 12, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiograph measurements

    5 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A single surgeon experience beginning in 2005 with patient's undergoing MPFL reconstruction using intra-operative fluoroscopy for proper placement of the femoral tunnel.

You may qualify if:

  • Patients having undergone the MPFL procedure, starting January 1, 2005 through February 3, 2010
  • Minimum follow up of 24 months

You may not qualify if:

  • Pregnant women
  • Under 18 years of age
  • Previously undergone prior MPFL surgery
  • Participated in any previous research studies involving the use of ionizing radiation (either radioisotopes or diagnostic x-rays during the past 12 months.
  • The participant should not volunteer for other research studies involving the use of ionizing radiation within 12 months of completing the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopedics Center

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • Robert T Burks, MD

    University of Utah Orthopaedic Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 29, 2011

Study Start

May 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations