Effect of Early Range of Motion Following First Time Patellar Dislocation

NCT ID: NCT04294199

Last Updated: 2023-12-18

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2026-08-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Patellar Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dual-arm randomized intervention comparison study evaluation two rehabilitation protocols for individuals following a first time lateral patella instability episode.
Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Early Range of MOtion

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Early Range of MOtion

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Immobilization Ear;y Range of Motion

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Scott McKay

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 25636989 (View on PubMed)

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.

Reference Type RESULT
PMID: 21962458 (View on PubMed)

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.

Reference Type RESULT
PMID: 26202017 (View on PubMed)

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.

Reference Type RESULT
PMID: 24636710 (View on PubMed)

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.

Reference Type RESULT
PMID: 24768468 (View on PubMed)

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.

Reference Type RESULT
PMID: 23714402 (View on PubMed)

Other Identifiers

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H43929

Identifier Type: -

Identifier Source: org_study_id

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