Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome (MPFL)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01405729
First received: July 27, 2011
Last updated: May 11, 2013
Last verified: May 2013
  Purpose
  1. To retrospectively quantify the accuracy of femoral tunnel insertion radiographically.
  2. To ensure correlation of validated knee scores with accurate femoral tunnel placement.

Condition
Healthy
Medial Patellofemoral Ligament Reconstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The purpose of our proposed retrospective study would be to determine our single surgeon's accuracy of femoral tunnel placement utilizing this method in patients having undergone this procedure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Participating patients will undergo 3 view x-ray series to determine accuracy in placement of the graft with respect to published norms. Average distance and errors from the mean would be calculated to determine the accuracy and precision of tunnel placement. A physical exam will be performed and a validated knee score questionnaire will be administered to evaluate a correlation or disparate clinical outcome in relation to femoral tunnel placement.


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Patellar subluxation or dislocation due to congenital/developmental disorders and/or traumatic injury to the knee is a correctable source of knee pain and dysfunction. Reconstruction of the medial patellofemoral ligament in these knees is accepted as one possible treatment for this disorder due to its restoration of the soft tissue static restraint to lateral subluxtion2-5. Prior studies have determined the anatomic location of the femoral insertion of this ligament as well as the need to restore this anatomy to achieve the goal of stability without creating abnormal contact pressures due to abnormal attachment6. Schottle et al in a cadaveric model described a radiographic method of identifying anatomic markers to properly place the femoral insertion of this ligament1. Schottle's study determined that using this method, all insertions specimens were found to be within 5mm of this ideal entry point1. The purpose of our proposed retrospective study would be to determine our single surgeon's accuracy of femoral tunnel placement utilizing this method in patients having undergone this procedure.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This would be a single surgeon experience beginning in 2005 with patient's undergoing MPFL reconstruction using intra-operative fluoroscopy for proper placement of the femoral tunnel. Consecutive series of patients would be selected beginning with change in surgical technique in 2005.

Criteria

Inclusion Criteria:

  • First step a retrospective chart review of patients having undergone the MPFL procedure, starting January 1, 2005 (the date that change in technique occurred) through December 31st 2009.

Exclusion Criteria:

  • Pregnant women are not eligible for participation. not participated in any previous research studies involving the use of ionizing radiation (either radioisotopes or diagnostic x-rays during the past 12 months. Further, the participant should not volunteer for other research studies involving the use of ionizing radiation within 12 months of completing the current study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405729

Locations
United States, Utah
University of Utah Orthopedics Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Robert T Burks, MD University of Utah Orthopaedic Center
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01405729     History of Changes
Other Study ID Numbers: 39977
Study First Received: July 27, 2011
Last Updated: May 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013