Effect of Early Range of Motion Following First Time Patellar Dislocation

Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar

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

Study Overview

• Status: Active, not recruiting
• Conditions: Patellar Dislocation
• Intervention / Treatment: Other: Early Range of MOtion

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.; Other Names: Immobilization; Ear;y Range of Motion
Experimental: Early range of motion; Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.	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.; Other Names: Immobilization; Ear;y Range of Motion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	Pain rated by patient on scale of 0-10.	1 minute

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Scott McKay, MD, Baylor College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): August 11, 2026

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: H43929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No