Patella Dislocation RecurrentNCT03040232
Clinical Outcomes Following Patellar Dislocation in Young Athletes
A study testing biomechanical assessment in people with Patella Dislocation Recurrent and Patellar Dislocation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to identify predictors of future injury and disability following LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with LPD following surgical and non-surgical management. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Patella Dislocation Recurrent, Patellar Dislocation
- What is being tested?
- biomechanical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2018
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants with LPD who have been managed with non-surgical rehabilitation, pre-surgical rehabilitation, and medial patellofemoral ligament reconstruction (MPFL-R) may be included.
- Participants may be included in this study is they have completed supervised rehabilitation and have been cleared to return to sports participation by their physician.
Who cannot join
- lower extremity orthopedic surgeries other than procedures for patellar instability
- lower extremity injuries within the last 3 months other than patellar dislocation
- neurological disorders
- medical conditions that might affect neuromuscular performance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of this study is to identify predictors of future injury and disability following LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with LPD following surgical and non-surgical management. Currently, there is limited information available to clinicians regarding appropriate criteria for returning athletes to sports participation following LPD. The evidence produced by this study will provide necessary information to develop appropriate rehabilitation strategies that may reduce the risk for future patellar instability and associated patellofemoral joint dysfunction and pain.
Read the detailed description
The basis of the proposed study is to determine the clinical outcomes following lateral patellar dislocation (LPD). Despite surgical and non-surgical interventions, young athletes are at high risk for sustaining subsequent dislocations that magnify the effects of disability. It is suspected that if athletes return to high-level activities and expose their knees to substantial forces without normalized movement strategies, then this may increase the risk for future joint injury. Currently, there are no evidence-based criteria to determine an athlete's readiness for sports activity following LPD. The purpose of this study is to characterize clinical outcomes, function, and neuromuscular control strategies employed by athletes following LPD at the time when they are returning to sports participation.
A prospective, longitudinal study design will be utilized. A cohort of up to 100 athletes (ages 12 - 25 years) who have sustained LPD during sports activities that require jumping, cutting, or pivoting maneuvers will be consecutively recruited from the offices of local orthopaedic surgeons, primary care physicians, and sports physical therapists for this study. Investigators will target a subset of surgically managed athletes and a subset of non-surgically managed athletes with LPD. A cohort of up to 100 individuals without history of knee injury will be recruited from local schools and universities to serve as control participants. Data will be collected to evaluate clinical outcomes, thigh and hip strength, lower body function, balance and neuromuscular control strategies. Clinical outcomes will be assessed using self-report questionnaires and performance-based measures, including hop and agility tests. Thigh and hip strength will be assessed utilizing an isokinetic dynamometer. Lower body function will be assessed using a series of single-leg and double-leg hopping tests. Balance will be assessed utilizing a clinical lower extremity reach test. Neuromuscular control will be evaluated by 3-D motion analysis during running, jumping, and cutting activities. Overall, this study will provide a comprehensive evaluation of athletes following LPD. It will provide important information for the future development of rehabilitation approaches that may maximize clinical outcomes for the at risk population.
- Being tested
- biomechanical assessment
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomechanical assessmentOther
biomechanical and strength assessment of both groups
| Study group | Role | What they receive |
|---|---|---|
| MPFl Reconstruction | Experimental | subjects that have had MPFL reconstruction surgery Receives: Other: biomechanical assessment |
| Active Controls | Active comparator | subjects that have not had MPFL reconstruction surgery Receives: Other: biomechanical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in biomechanical assessment using motion analysis
measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella Dislocation RecurrentStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory D Myer, PhD, Principal investigator, Cincinanti Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040232
- Sponsor's protocol ID
- 2011-1984
- Status last verified
- Jul 2020
- First submitted
- 10 Jan 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Following Patellar Dislocation in Young Athletes
- ClinicalTrials.gov ID
- NCT03040232
- Acronym / sponsor ID
- 2011-1984
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Feb 2017 (estimated)
- 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.
The purpose of this study is to identify predictors of future injury and disability following LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with LPD following surgical and non-surgical management. Currently, there is limited information available to clinicians regarding appropriate criteria for returning athletes to sports participation following LPD. The evidence produced by this study will provide necessary information to develop appropriate rehabilitation strategies that may reduce the risk for future patellar instability and associated patellofemoral joint dysfunction and pain.
Detailed description
The basis of the proposed study is to determine the clinical outcomes following lateral patellar dislocation (LPD). Despite surgical and non-surgical interventions, young athletes are at high risk for sustaining subsequent dislocations that magnify the effects of disability. It is suspected that if athletes return to high-level activities and expose their knees to substantial forces without normalized movement strategies, then this may increase the risk for future joint injury. Currently, there are no evidence-based criteria to determine an athlete's readiness for sports activity following LPD. The purpose of this study is to characterize clinical outcomes, function, and neuromuscular control strategies employed by athletes following LPD at the time when they are returning to sports participation.
A prospective, longitudinal study design will be utilized. A cohort of up to 100 athletes (ages 12 - 25 years) who have sustained LPD during sports activities that require jumping, cutting, or pivoting maneuvers will be consecutively recruited from the offices of local orthopaedic surgeons, primary care physicians, and sports physical therapists for this study. Investigators will target a subset of surgically managed athletes and a subset of non-surgically managed athletes with LPD. A cohort of up to 100 individuals without history of knee injury will be recruited from local schools and universities to serve as control participants. Data will be collected to evaluate clinical outcomes, thigh and hip strength, lower body function, balance and neuromuscular control strategies. Clinical outcomes will be assessed using self-report questionnaires and performance-based measures, including hop and agility tests. Thigh and hip strength will be assessed utilizing an isokinetic dynamometer. Lower body function will be assessed using a series of single-leg and double-leg hopping tests. Balance will be assessed utilizing a clinical lower extremity reach test. Neuromuscular control will be evaluated by 3-D motion analysis during running, jumping, and cutting activities. Overall, this study will provide a comprehensive evaluation of athletes following LPD. It will provide important information for the future development of rehabilitation approaches that may maximize clinical outcomes for the at risk population.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPFl Reconstruction | Experimental | Other: biomechanical assessmentsubjects that have had MPFL reconstruction surgery |
| Active Controls | Active comparator | Other: biomechanical assessmentsubjects that have not had MPFL reconstruction surgery |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants with LPD who have been managed with non-surgical rehabilitation, pre-surgical rehabilitation, and medial patellofemoral ligament reconstruction (MPFL-R) may be included.
- Participants may be included in this study is they have completed supervised rehabilitation and have been cleared to return to sports participation by their physician.
Key exclusion criteria (4 listed)
- lower extremity orthopedic surgeries other than procedures for patellar instability
- lower extremity injuries within the last 3 months other than patellar dislocation
- neurological disorders
- medical conditions that might affect neuromuscular performance.
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 |
|---|---|---|
| biomechanical assessmentbiomechanical and strength assessment of both groups | Other | Active Controls, MPFl Reconstruction |
Primary outcome
change in biomechanical assessment using motion analysis
Time frame: 6 months
measure changes in biomechanics between groups using motion analysis with particular interest in knee valgus measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Patella Dislocation Recurrent
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
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
Recruiting
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
Patellar Instability
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.
Gregory D Myer, PhD principal investigator
Cincinanti Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biomechanical assessment in people with Patella Dislocation Recurrent and Patellar Dislocation, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in biomechanical assessment using motion analysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2020.