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CompletedNCT03040232Updated Jul 15, 2020

Clinical Outcomes Following Patellar Dislocation in Young Athletes

An interventional study of biomechanical assessment in Patella Dislocation Recurrent and Patellar Dislocation, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 12 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
12 Years to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patella Dislocation Recurrent
  • Patellar Dislocation
03

Who can participate

Ages eligible
12 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    MPFl Reconstruction

    subjects that have had MPFL reconstruction surgery

    Other: biomechanical assessment

  • Active comparator
    Active Controls

    subjects that have not had MPFL reconstruction surgery

    Other: biomechanical assessment

Interventions

  • Otherbiomechanical assessment

    biomechanical and strength assessment of both groups

05

What researchers measure

Primary outcomes

  1. change in biomechanical assessment using motion analysis

    measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures

    Time frame: 6 months

06

Study locations

1 site
  • Cincinnati Childrens Hospital Medical Center
    Cincinnati, Ohio 45229, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03040232
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Feb 2, 2017
Start date
Jan 2016
Primary completion
Dec 2017
Completion
Jun 2018
Last update
Jul 15, 2020

Study contacts

Gregory D Myer, PhD
principal investigator · Cincinanti Childrens Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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