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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01405729
Other study ID # 39977
Secondary ID
Status Completed
Phase N/A
First received July 27, 2011
Last updated February 12, 2014
Start date May 2010
Est. completion date December 2013

Study information

Verified date February 2014
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Reconstruction of the medial patellofemoral ligament (MPFL) has been shown to be an effective treatment for recurrent patellar instability, There has been some concern in the literature about the accuracy of femoral tunnel placement and the effect that it might have on patient outcomes.

The investigators evaluated the accuracy of MPFL placement using an intraopetative fluoroscopy technique and to assess subsequent patient outcomes.

All patients undergoing MPFL reconstruction using an intraoperative fluoroscopically guided technique between 2005 and 2010 were identified. A retrospective review of their charts and radiographs were performed and the subjects were brought back for a follow up exam, radiographic series, and Kujala questionaire.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients having undergone the MPFL procedure, starting January 1, 2005 through February 3, 2010

- Minimum follow up of 24 months

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Healthy
  • Medial Patellofemoral Ligament Reconstruction

Locations

Country Name City State
United States University of Utah Orthopedics Center Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiograph measurements 5 years No
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