Effect of Early Range of Motion Following First Time Patellar Dislocation

Overview

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

Full Title of Study: “Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 15, 2024

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.

Interventions

  • Other: Early Range of MOtion
    • Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.

Arms, Groups and Cohorts

  • Active Comparator: Immobilization
    • Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment
  • Experimental: Early range of motion
    • Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.

Clinical Trial Outcome Measures

Primary Measures

  • Kujala Knee Score
    • Time Frame: 10 minutes
    • 13 item questionnaire to rate pain, function, ambulation, and instability
  • Tegner Activity Scale
    • Time Frame: 5 minutes
    • 11 levels of activity from complete inability to function to advanced sports participation
  • Isokinetic Strength using Biodex
    • Time Frame: 30 minutes
    • Force of movement is measured in newtons and torque and corrected for body weight
  • Passive Range of Motion
    • Time Frame: 5 minutes
    • Measured with goniometer to record full range of motion in knee flexion and extension
  • Edema Assessment
    • Time Frame: 2 minutes
    • Measure of knee circumference

Secondary Measures

  • Numerical Pain Rating Scale
    • Time Frame: 1 minute
    • Pain rated by patient on scale of 0-10.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Scott McKay, Principal Investigator – Baylor College of Medicine
  • Overall Official(s)
    • Scott McKay, MD, Principal Investigator, Baylor College of Medicine

References

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.

Citations Reporting on Results

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.

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.

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.

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.

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.

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