Effect of Early Range of Motion Following First Time Patellar Dislocation

NCT04294199 | Active Not Recruiting

• 1 other identifier: H43929
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patellar Dislocation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Numerical Pain Rating Scale

  1 minute

Study Arms (2)

Immobilization

ACTIVE COMPARATOR

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

Early range of motion

EXPERIMENTAL

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

Other: Early Range of MOtion

Interventions

Early Range of MOtion OTHER

Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.

Also known as: Immobilization, Ear;y Range of Motion

Early range of motion; Immobilization

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (6)

• 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.

  PMID: 25636989 BACKGROUND

• 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.

  PMID: 21962458 RESULT

• 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.

  PMID: 26202017 RESULT

• 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.

  PMID: 24636710 RESULT

• 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.

  PMID: 24768468 RESULT

• 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.

  PMID: 23714402 RESULT

MeSH Terms

Conditions

Patellar Dislocation

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Scott McKay, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dual-arm randomized intervention comparison study evaluation two rehabilitation protocols for individuals following a first time lateral patella instability episode.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: October 31, 2018
• Primary Completion: June 15, 2024
• Study Completion (Estimated): August 11, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)