Prospective Clinical Study of Excessive Lateral Pressure Syndrome

July 25, 2021 updated by: Peking University Third Hospital
The study of July 2021 to July 2022 to undergraduate course to see a doctor and accept the lateral retinaculum capsule of external release the prospectie study of 100 patients with follow-up, compared with preoperative and postoperative imaging data, clinical manifestations, signs, etc., to evaluate the surgical effect, at the same time of resection specimens for pathology and genetics research,To investigate the pathogenesis of lateral patella compression syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Excessive Lateral Pressure Syndrome (ELPS) is a series of clinical symptoms caused by various factors, such as patella tilt, adaptive contraction of the Lateral retinaculum and unbalanced Pressure on the medial and Lateral joint surfaces of the patellofemoral. The concept was first proposed by Ficat in 1977. Patellofemoral pain syndrome has long been lumped together as widespread pregenitual pain and Patella malalignment syndrome as Patellofemoral pain due to poor Patella alignment.Kramer et al. found that the main cause of patellofemoral pain and increased pressure on the lateral patellofemoral surface was excessive pressure on the lateral retinol. Later, this view was accepted by more scholars, and lateral patellofemoral compression syndrome was gradually regarded as an independent syndrome and more studies were conducted.

In patients with lateral patella compression syndrome, early manifestations are usually pain in the soft tissues around the patella. Fulkerson et al. in 1985 found pathological changes in the nerve fibers in the lateral retinaculum through a pathological study, which is the basis for early lesions showing only pain in the soft tissues around the patella.As the disease progresses, uneven pressure on the medial and lateral facets of the patellofemoral joint will gradually lead to damage of the medial and lateral facets of the articular cartilage, eventually leading to irreversible damage of the articular cartilage and osteoarthritis.

The surgical treatment of lateral compression syndrome is varied, and in recent years, the most commonly used surgical methods include: incision lysis, percutaneous lysis, arthroscope-assisted percutaneous lysis, arthroscopic release, etc.These traditional surgical methods all have obvious complications, such as intraarticular dislocation of patella, recurrence of lateral compression due to postoperative adhesion of the support band, patellofemoral joint instability, intraarticular hematoma, etc.Although there are many surgical treatment methods for lateral compression syndrome, there is still no recognized standard treatment. Due to the fact that its effect and evaluation criteria cannot be unified, accurate horizontal comparison cannot be made among different regions and different populations.

Made by the researchers of the lateral retinaculum extracapsular release, at the same time in the release of the lateral retinaculum complete retaining articular capsule and lateral patellofemoral ligament, this procedure can obviously improve patellofemoral joint trajectory anomalies and significantly reduce joint surface pressure, at the same time reduce the surgical trauma, try to keep the original structure, can greatly reduce the postoperative complications of patellofemoral joint.

Studied in this paper in March 2021 to March 2022 to undergraduate course to see a doctor and accept the lateral retinaculum capsule of external release the prospective study of 100 patients with follow-up, compared with preoperative and postoperative imaging data, clinical manifestations, signs, etc., to evaluate the surgical effect, at the same time of resection specimens for pathology and genetics research,To investigate the pathogenesis of lateral patella compression syndrome.

Through this study, to explore the etiology, development and outcome of the disease, is helpful for the early diagnosis and treatment of the disease, avoid the irreversible injury of the patient's knee joint, greatly improve the quality of life of patients, reduce the incidence of knee replacement, and save medical resources.At the same time, the external capsule release of the lateral retinacular joint created by the present study will have a profound impact on the surgical treatment of the lateral retinacular joint.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Young and middle-aged sports active people

Description

Inclusion Criteria:

  • Inclusion criteria:

    1. Age <40.
    2. Normal strength line of lower limbs: no valgus or varus feet (HKA <±5°)

Exclusion Criteria:

  1. Combined patella dislocation and medial retinacular injury.
  2. Have a history of knee surgery, knee injury and fracture.
  3. Complicated cruciate ligament injury and medial and lateral collateral ligament injury.
  4. Combined knee osteoarthritis.
  5. Complicated with rheumatism, rheumatoid arthritis and other types of arthritis
  6. Patellar bisection, trochlear dysplasia
  7. Gouty arthritis and hyperuricemia of the knee
  8. Complicated meniscus injury of degree III or above
  9. Incorporating lateral discoid meniscus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
observation group
People suffered from excessive lateral pressure syndrome with extracapsular release of lateral retinaculum.
Procedure: extracapsular release of lateral retinaculum
A new kind of surgery releases the lateral retinaculum from outside the knee capsular, maintaining the structure of the knee capsular.
control group
People suffered from excessive lateral pressure syndrome with conservative treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of lesions
Time Frame: 2years
The improvement of cartilage injury of patellofemoral joint and tibiofemoral joint. Two senior surgeons read the MRI separately, recording the status of lesion area. The lesion area was compared before and after surgery. Using Outerbridge Classification to evaluate the severity of cartilage injury.
2years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain severity change
Time Frame: 2years
Using Visual Analog Pain Scale for pain evaluating pain severity.The score ranks from 0 to 10. 0 means "no pain", 10 means "the pain is intolerable". The higher the score, the more pain the patient suffers.
2years
Clinical symptom change
Time Frame: 2years
Using Kujala score for symptom change.
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Weihai Wendeng District Central Hospital
Inner Mongolia Autonomous Region Hospital
Beijing Delconi Orthopaedic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2020527

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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