Patellar DislocationNCT04294199
Effect of Early Range of Motion Following First Time Patellar Dislocation
A study testing Early Range of MOtion in people with Patellar Dislocation, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Do teen-age patients with a dislocated knee cap do better with or without a brace? Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Patellar Dislocation
- What is being tested?
- Early Range of MOtion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 11 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar
Do teen-age patients with a dislocated knee cap do better with or without a brace?
Read the 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.
- Conditions
- Patellar Dislocation
- Being tested
- Early Range of MOtion
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Range of MOtionOther
Also called Immobilization, Ear;y 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Early Range of MOtion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala Knee Score
13 item questionnaire to rate pain, function, ambulation, and instability
Measured: 10 minutes
Tegner Activity Scale
11 levels of activity from complete inability to function to advanced sports participation
Measured: 5 minutes
Isokinetic Strength using Biodex
Force of movement is measured in newtons and torque and corrected for body weight
Measured: 30 minutes
Passive Range of Motion
Measured with goniometer to record full range of motion in knee flexion and extension
Measured: 5 minutes
Edema Assessment
Measure of knee circumference
Measured: 2 minutes
Secondary outcomes (1)
Numerical Pain Rating Scale
Pain rated by patient on scale of 0-10.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start31 Oct 2018
- Primary completion15 Jun 2024 (estimated)
- Study completion11 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patellar DislocationStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott McKay, Baylor College of Medicine
- Investigators
- Scott McKay, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294199
- Sponsor's protocol ID
- H43929
- Status last verified
- Dec 2023
- First submitted
- 2 Mar 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25636989Armstrong 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.
PubMed 21962458Saccomanno 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.
PubMed 26202017Cheng 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.
PubMed 24636710Matic 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.
PubMed 24768468Vavken 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.
PubMed 23714402
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar
- ClinicalTrials.gov ID
- NCT04294199
- Acronym / sponsor ID
- H43929
- Conditions
- Patellar Dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 11 Aug 2026 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dual-arm randomized intervention comparison study evaluation two rehabilitation protocols for individuals following a first time lateral patella instability episode.
| Arm | Type | Receives |
|---|---|---|
| Immobilization | Active comparator | Other: Early Range of MOtionPatients 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 | Experimental | Other: Early Range of MOtionPatients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Range of MOtionAlso: Immobilization, Ear;y Range of MotionGroups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation. | Other | Early range of motion, Immobilization |
Primary outcome
Kujala Knee Score
Time frame: 10 minutes
13 item questionnaire to rate pain, function, ambulation, and instability
Tegner Activity Scale
Time frame: 5 minutes
11 levels of activity from complete inability to function to advanced sports participation
Isokinetic Strength using Biodex
Time frame: 30 minutes
Force of movement is measured in newtons and torque and corrected for body weight
Passive Range of Motion
Time frame: 5 minutes
Measured with goniometer to record full range of motion in knee flexion and extension
Edema Assessment
Time frame: 2 minutes
Measure of knee circumference
1 secondary outcome
Numerical Pain Rating Scale
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 25636989Erickson 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 publication: PubMed 21962458Armstrong 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 publication: PubMed 26202017Saccomanno 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 publication: PubMed 24636710Cheng 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 publication: PubMed 24768468Matic 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 publication: PubMed 23714402Vavken 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.
- Individual participant dataSharing planned: No
Related trials for Patellar Dislocation
Recruiting
Blood Flow Restriction Training After Patellar INStability
Patellar Dislocation, Knee Injuries
Not yet recruiting
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
Recurrent Patellar Displacement, MPFL
Recruiting
Effects of Preoperative Rehabilitation on Tendon Healing, Bone Mineral Density, and Cartilage After ACLR and Patellar Dislocation
Anterior Cruciate Ligament Rupture
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
Enrolling by invitationObservational study
Arthroscopic Trochleaplasty in Chronic Relapsing Patellar Dislocations: A Follow-up Study
Patellar Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott McKay, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Range of MOtion in people with Patellar Dislocation, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kujala Knee Score (time frame: 10 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294199, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.