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The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction (TT-TG Outcome)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076008
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
Ohio State University
OrthoSport Victoria
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The investigators plan to perform a prospective observational cohort study of patients undergoing MPFL reconstruction for the treatment of episodic patellar instability in the absence of significant degenerative disease. The investigators will follow these study subjects for a minimum of two years to monitor their functional and clinical outcome.

Condition or disease Intervention/treatment
Patellar Dislocation Other: Observational

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MPFL Reconstruction
Subjects undergoing MPFL Reconstruction
Other: Observational
No intervention




Primary Outcome Measures :
  1. Recurrent Dislocation [ Time Frame: 2 years ]
    Recurrent Dislocation



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing MPFL reconstruction for patella instability
Criteria

Inclusion Criteria:

  • MPFL Reconstruction

Exclusion Criteria:

  • Trochleoplasty Required
  • Prior ipsilateral knee surgery
  • Iwano grade 2+
  • CHondral injury requiring surgical treatment beyond debridement
  • Major ligamentous injury to the knee

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076008


Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Julie Agel    612-273-8000      
Sponsors and Collaborators
University of Minnesota
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
Ohio State University
OrthoSport Victoria

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03076008    
Other Study ID Numbers: 1604M86744
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are currently undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Patellar Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries