Effect of Early Range of Motion Following First Time Patellar Dislocation
NCT ID: NCT04294199
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2018-10-31
2026-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
Early range of motion
Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
11 Years
17 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Scott McKay
Principal Investigator
Principal Investigators
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Scott McKay, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Texas Children's Hospital
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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H43929
Identifier Type: -
Identifier Source: org_study_id
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