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Clinical Outcomes Following Patellar Dislocation in Young Athletes

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ClinicalTrials.gov Identifier: NCT03040232
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date July 15, 2020
Study Start Date  ICMJE January 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
change in biomechanical assessment using motion analysis [ Time Frame: 6 months ]
measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Outcomes Following Patellar Dislocation in Young Athletes
Official Title  ICMJE Clinical Outcomes Following Patellar Dislocation in Young Athletes
Brief Summary The purpose of this study is to identify predictors of future injury and disability following LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with LPD following surgical and non-surgical management. Currently, there is limited information available to clinicians regarding appropriate criteria for returning athletes to sports participation following LPD. The evidence produced by this study will provide necessary information to develop appropriate rehabilitation strategies that may reduce the risk for future patellar instability and associated patellofemoral joint dysfunction and pain.
Detailed Description

The basis of the proposed study is to determine the clinical outcomes following lateral patellar dislocation (LPD). Despite surgical and non-surgical interventions, young athletes are at high risk for sustaining subsequent dislocations that magnify the effects of disability. It is suspected that if athletes return to high-level activities and expose their knees to substantial forces without normalized movement strategies, then this may increase the risk for future joint injury. Currently, there are no evidence-based criteria to determine an athlete's readiness for sports activity following LPD. The purpose of this study is to characterize clinical outcomes, function, and neuromuscular control strategies employed by athletes following LPD at the time when they are returning to sports participation.

A prospective, longitudinal study design will be utilized. A cohort of up to 100 athletes (ages 12 - 25 years) who have sustained LPD during sports activities that require jumping, cutting, or pivoting maneuvers will be consecutively recruited from the offices of local orthopaedic surgeons, primary care physicians, and sports physical therapists for this study. Investigators will target a subset of surgically managed athletes and a subset of non-surgically managed athletes with LPD. A cohort of up to 100 individuals without history of knee injury will be recruited from local schools and universities to serve as control participants. Data will be collected to evaluate clinical outcomes, thigh and hip strength, lower body function, balance and neuromuscular control strategies. Clinical outcomes will be assessed using self-report questionnaires and performance-based measures, including hop and agility tests. Thigh and hip strength will be assessed utilizing an isokinetic dynamometer. Lower body function will be assessed using a series of single-leg and double-leg hopping tests. Balance will be assessed utilizing a clinical lower extremity reach test. Neuromuscular control will be evaluated by 3-D motion analysis during running, jumping, and cutting activities. Overall, this study will provide a comprehensive evaluation of athletes following LPD. It will provide important information for the future development of rehabilitation approaches that may maximize clinical outcomes for the at risk population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Patella Dislocation Recurrent
  • Patellar Dislocation
Intervention  ICMJE Other: biomechanical assessment
biomechanical and strength assessment of both groups
Study Arms  ICMJE
  • Experimental: MPFl Reconstruction
    subjects that have had MPFL reconstruction surgery
    Intervention: Other: biomechanical assessment
  • Active Comparator: Active Controls
    subjects that have not had MPFL reconstruction surgery
    Intervention: Other: biomechanical assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
100
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with LPD who have been managed with non-surgical rehabilitation, pre-surgical rehabilitation, and medial patellofemoral ligament reconstruction (MPFL-R) may be included.
  • Participants may be included in this study is they have completed supervised rehabilitation and have been cleared to return to sports participation by their physician.

Exclusion Criteria:

  1. lower extremity orthopedic surgeries other than procedures for patellar instability
  2. lower extremity injuries within the last 3 months other than patellar dislocation
  3. neurological disorders
  4. medical conditions that might affect neuromuscular performance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040232
Other Study ID Numbers  ICMJE 2011-1984
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory D Myer, PhD Cincinanti Childrens Hospital
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP