- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040232
Clinical Outcomes Following Patellar Dislocation in Young Athletes
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Childrens Hospital Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MPFl Reconstruction
subjects that have had MPFL reconstruction surgery
|
biomechanical and strength assessment of both groups
|
ACTIVE_COMPARATOR: Active Controls
subjects that have not had MPFL reconstruction surgery
|
biomechanical and strength assessment of both groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-1984
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellar Dislocation
-
Hui ZhangNot yet recruiting
-
Finnish Defense ForcesTampere University HospitalTerminatedPatellofemoral Osteoarthritis | Patellar Instability | Patella-DislocationFinland
-
Hospices Civils de LyonActive, not recruitingEpisodic Patellar DislocationFrance
-
Polish Mother Memorial Hospital Research InstituteCompletedThe Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.Recurrent Patellar Dislocation | Patellar InstabilityPoland
-
Beijing Jishuitan HospitalNot yet recruitingRecurrent Patellar Dislocation | Osteotomy | Patellar Maltracking
-
Artromedical Konrad Malinowski ClinicRecruitingLateral Patellofemoral Dislocation Closed Traumatic | Lateral Patellar LuxationPoland
-
Polish Mother Memorial Hospital Research InstituteCompletedPatellofemoral Osteoarthritis | Recurrent Patellar Dislocation | Patellar InstabilityPoland
-
Radboud University Medical CenterRecruitingPatellar Dislocation | Patellofemoral Maltracking | Patellar Dislocation, RecurrentNetherlands
-
Peking University Third HospitalRecruitingRecurrent Patellar DislocationChina
-
Ramsay Générale de SantéEuropean Clinical Trial Experts Network; Dr Vincent ChassaingCompletedPatellar Dislocation | Patellar InstabilityFrance
Clinical Trials on biomechanical assessment
-
Istituto Ortopedico RizzoliCompletedFrail Elderly SyndromeItaly
-
Masaryk UniversityVSB - Technical University of OstravaActive, not recruiting
-
Riphah International UniversityCompletedPronation; Ankle | DistortionPakistan
-
University of FloridaUniversity of South Florida; National Institute of Neurological Disorders and...CompletedSpinocerebellar AtaxiaUnited States
-
Centre hospitalier de l'Université de Montréal...MedTeq; Natural Sciences and Engineering Research Council, Canada; Siemens Corporation...Recruiting
-
Medipol UniversityCompleted
-
Hillel Yaffe Medical CenterUnknown
-
Advanced Tactile Imaging, Inc.Princeton UrogynecologyCompleted
-
Assaf-Harofeh Medical CenterUnknown
-
Asir John SamuelCompletedOsteoarthritis KneeIndia