Clinical Outcomes Following Patellar Dislocation in Young Athletes
Primary Purpose
Patella Dislocation Recurrent, Patellar Dislocation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
biomechanical assessment
Sponsored by
About this trial
This is an interventional screening trial for Patella Dislocation Recurrent
Eligibility Criteria
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:
- lower extremity orthopedic surgeries other than procedures for patellar instability
- lower extremity injuries within the last 3 months other than patellar dislocation
- neurological disorders
- medical conditions that might affect neuromuscular performance.
Sites / Locations
- Cincinnati Childrens Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MPFl Reconstruction
Active Controls
Arm Description
subjects that have had MPFL reconstruction surgery
subjects that have not had MPFL reconstruction surgery
Outcomes
Primary Outcome Measures
change in biomechanical assessment using motion analysis
measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03040232
First Posted
January 10, 2017
Last Updated
July 13, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03040232
Brief Title
Clinical Outcomes Following Patellar Dislocation in Young Athletes
Official Title
Clinical Outcomes Following Patellar Dislocation in Young Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella Dislocation Recurrent, Patellar Dislocation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MPFl Reconstruction
Arm Type
Experimental
Arm Description
subjects that have had MPFL reconstruction surgery
Arm Title
Active Controls
Arm Type
Active Comparator
Arm Description
subjects that have not had MPFL reconstruction surgery
Intervention Type
Other
Intervention Name(s)
biomechanical assessment
Intervention Description
biomechanical and strength assessment of both groups
Primary Outcome Measure Information:
Title
change in biomechanical assessment using motion analysis
Description
measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
lower extremity orthopedic surgeries other than procedures for patellar instability
lower extremity injuries within the last 3 months other than patellar dislocation
neurological disorders
medical conditions that might affect neuromuscular performance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Cincinanti Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcomes Following Patellar Dislocation in Young Athletes
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