Effect of Early Range of Motion Following First Time Patellar Dislocation

Patellar Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04294199
• Other study ID #: H43929
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: August 11, 2026

Study information

• Verified date: December 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 11, 2026
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellar Dislocation

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (6)

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: 1 — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kujala Knee Score	13 item questionnaire to rate pain, function, ambulation, and instability	10 minutes
Primary	Tegner Activity Scale	11 levels of activity from complete inability to function to advanced sports participation	5 minutes
Primary	Isokinetic Strength using Biodex	Force of movement is measured in newtons and torque and corrected for body weight	30 minutes
Primary	Passive Range of Motion	Measured with goniometer to record full range of motion in knee flexion and extension	5 minutes
Primary	Edema Assessment	Measure of knee circumference	2 minutes
Secondary	Numerical Pain Rating Scale	Pain rated by patient on scale of 0-10.	1 minute