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Effect of Early Range of Motion Following First Time Patellar Dislocation

Primary Purpose

Patellar Dislocation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Range of MOtion
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Dislocation

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immobilization

Early range of motion

Arm Description

Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment

Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Numerical Pain Rating Scale
Pain rated by patient on scale of 0-10.

Full Information

First Posted
March 2, 2020
Last Updated
May 29, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04294199
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
August 11, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Dual-arm randomized intervention comparison study evaluation two rehabilitation protocols for individuals following a first time lateral patella instability episode.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immobilization
Arm Type
Active Comparator
Arm Description
Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment
Arm Title
Early range of motion
Arm Type
Experimental
Arm Description
Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.
Intervention Type
Other
Intervention Name(s)
Early Range of MOtion
Other Intervention Name(s)
Immobilization, Ear;y Range of Motion
Intervention Description
Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.
Primary Outcome Measure Information:
Title
Kujala Knee Score
Description
13 item questionnaire to rate pain, function, ambulation, and instability
Time Frame
10 minutes
Title
Tegner Activity Scale
Description
11 levels of activity from complete inability to function to advanced sports participation
Time Frame
5 minutes
Title
Isokinetic Strength using Biodex
Description
Force of movement is measured in newtons and torque and corrected for body weight
Time Frame
30 minutes
Title
Passive Range of Motion
Description
Measured with goniometer to record full range of motion in knee flexion and extension
Time Frame
5 minutes
Title
Edema Assessment
Description
Measure of knee circumference
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
Pain rated by patient on scale of 0-10.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott McKay, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25636989
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.
Results Reference
background
PubMed Identifier
21962458
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.
Results Reference
result
PubMed Identifier
26202017
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.
Results Reference
result
PubMed Identifier
24636710
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.
Results Reference
result
PubMed Identifier
24768468
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.
Results Reference
result
PubMed Identifier
23714402
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.
Results Reference
result

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Effect of Early Range of Motion Following First Time Patellar Dislocation

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