HealthyMPFLNCT01405729
Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome
An observational study of Healthy and Medial Patellofemoral Ligament Reconstruction, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Medial Patellofemoral Ligament Reconstruction
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients having undergone the MPFL procedure, starting January 1, 2005 through February 3, 2010
- Minimum follow up of 24 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics Center
Salt Lake City, Utah, 84108
About this study
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.
Read the detailed 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiograph measurements
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Burks, University of Utah
- Investigators
- Robert T Burks, MD, Principal investigator, University of Utah Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405729
- Sponsor's protocol ID
- 39977
- Acronym
- MPFL
- Status last verified
- Feb 2014
- First submitted
- 27 Jul 2011
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome
- ClinicalTrials.gov ID
- NCT01405729
- Acronym / sponsor ID
- MPFL / 39977
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients having undergone the MPFL procedure, starting January 1, 2005 through February 3, 2010
- Minimum follow up of 24 months
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiograph measurements
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert T Burks, MD principal investigator
University of Utah Orthopaedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Medial Patellofemoral Ligament Reconstruction, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiograph measurements (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.