Clinical trial NCT04294199: Effect of Early Range of Motion Following First Time Patellar Dislocation
Official title: Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patellar Dislocation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dual-arm randomized intervention comparison study evaluation two rehabilitation protocols for individuals following a first time lateral patella instability episode.
Primary purpose: TREATMENT

Brief summary: Do teen-age patients with a dislocated knee cap do better with or without a brace?

Detailed description: This study will look at two different ways to treat teen-age patients who have had a dislocation of their knee cap. Both groups will receive the physical therapy treatment for knee cap dislocation but one group will first be in a brace for a week and the other group will start moving in therapy right away.

Eligibility criteria: Inclusion Criteria:

* Male and female adolescents between 11-17 years
* Medical diagnosis of 1st time lateral patellar instability episode (dislocation or subluxation)
* Subjective history of knee shifting, instability, popping out, knee effusion
* Apprehension test is positive and has medial patellar tenderness
* Referred to the Texas Children's Hospital (TCH) outpatient sports medicine clinic from an emergency room facility, urgent care or pediatrician within 10 days of the injury.
* Free of co-morbidities that would prevent or limit rehabilitation including cardiac, pulmonary, psychiatric (except Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD), orthopedic, neurological
* Must be able to follow directions and participate in rehabilitation protocol for the 3-month study period.

Exclusion Criteria:

* Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.

Primary outcomes:
measure: Kujala Knee Score
timeFrame: 10 minutes
measure: Tegner Activity Scale
timeFrame: 5 minutes
measure: Isokinetic Strength using Biodex
timeFrame: 30 minutes
measure: Passive Range of Motion
timeFrame: 5 minutes
measure: Edema Assessment
timeFrame: 2 minutes
Secondary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: 1 minute
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Scott McKay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erickson BJ, Mascarenhas R, Sayegh ET, Saltzman B, Verma NN, Bush-Joseph CA, Cole BJ, Bach BR Jr. Does Operative Treatment of First-Time Patellar Dislocations Lead to Increased Patellofemoral Stability? A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Jun;31(6):1207-15. doi: 10.1016/j.arthro.2014.11.040. Epub 2015 Jan 28.
citation: Armstrong BM, Hall M, Crawfurd E, Smith TO. A feasibility study for a pragmatic randomised controlled trial comparing cast immobilisation versus no immobilisation for patients following first-time patellar dislocation. Knee. 2012 Oct;19(5):696-702. doi: 10.1016/j.knee.2011.08.004. Epub 2011 Sep 29.
citation: Saccomanno MF, Sircana G, Fodale M, Donati F, Milano G. Surgical versus conservative treatment of primary patellar dislocation. A systematic review and meta-analysis. Int Orthop. 2016 Nov;40(11):2277-2287. doi: 10.1007/s00264-015-2856-x. Epub 2015 Jul 23.
citation: Cheng B, Wu X, Ge H, Qing Sun Y, Zhang Q. Operative versus conservative treatment for patellar dislocation: a meta-analysis of 7 randomized controlled trials. Diagn Pathol. 2014 Mar 18;9:60. doi: 10.1186/1746-1596-9-60.
citation: Matic GT, Magnussen RA, Kolovich GP, Flanigan DC. Return to activity after medial patellofemoral ligament repair or reconstruction. Arthroscopy. 2014 Aug;30(8):1018-25. doi: 10.1016/j.arthro.2014.02.044. Epub 2014 Apr 24.
citation: Vavken P, Wimmer MD, Camathias C, Quidde J, Valderrabano V, Pagenstert G. Treating patella instability in skeletally immature patients. Arthroscopy. 2013 Aug;29(8):1410-22. doi: 10.1016/j.arthro.2013.03.075. Epub 2013 May 25.