NCT03040232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

January 10, 2017

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

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

    6 months

Study Arms (2)

MPFl Reconstruction

EXPERIMENTAL

subjects that have had MPFL reconstruction surgery

Other: biomechanical assessment

Active Controls

ACTIVE COMPARATOR

subjects that have not had MPFL reconstruction surgery

Other: biomechanical assessment

Interventions

biomechanical and strength assessment of both groups

Active ControlsMPFl Reconstruction

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Officials

  • Gregory D Myer, PhD

    Cincinanti Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

February 2, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations