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Excessive Lateral Pressure SyndromeNCT04977492

Retrospective Clinical Study of Excessive Lateral Pressure Syndrome

An observational study of Excessive Lateral Pressure Syndrome, run by Peking University Third Hospital.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research focuses on 1 January 2015 to December 2018 to the undergraduate course to see a doctor and accept the lateral retinaculum extracapsular release of 100 patients were retrospectively study, through the follow-up, compare the preoperative and postoperative radiographic data, clinical manifestations, signs… Read more about this study

Who is it for?
Ages Up to 40 yearsHealthy volunteers can take part
Conditions the study is for
Excessive Lateral Pressure Syndrome
What is being tested?
extracapsular release of lateral retinaculum
Type of treatment
Surgery or procedure
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jan 2015to 1 Jun 2021
Phase
Observational
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 Up to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Young and middle-aged sports active people

Who may be able to join

  • Age <40.
  • Normal lower limb strength line: no valgus or varus feet, no hyperpronation of hind feet, negative J sign.

Who cannot join

  • Combined patella instability and patella dislocation.
  • Have a history of knee surgery and knee fracture.
  • Complicated cruciate ligament injury and medial and lateral collateral ligament injury.
  • Osteoarthritis of the knee.

About this study

This research focuses on 1 January 2015 to December 2018 to the undergraduate course to see a doctor and accept the lateral retinaculum extracapsular release of 100 patients were retrospectively study, through the follow-up, compare the preoperative and postoperative radiographic data, clinical manifestations, signs, etc., to evaluate the surgical effect and explore the pathogenesis of patellar lateral compression syndrome.

Read the 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 retinacular 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 retinaculum. 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 intra-articular dislocation of patella, recurrence of lateral compression due to postoperative adhesion of the support band, patellofemoral joint instability, intra-articular 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.

Sports medicine, Peking University third hospital Guoqing Cui, a professor at the set 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,The complication of patellofemoral joint can be greatly reduced.

This research focuses on 1 January 2015 to December 2018 to the undergraduate course to see a doctor and accept the lateral retinaculum extracapsular release of 100 patients were retrospectively study, through the follow-up, compare the preoperative and postoperative radiographic data, clinical manifestations, signs, etc., to evaluate the surgical effect and explore the pathogenesis of patellar lateral 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 Professor Cui Guoqing will have a profound impact on the surgical treatment of the lateral retinacular joint.

Being tested
extracapsular release of lateral retinaculum
Keywords
excessive lateral pressure syndrome, patellofemoral joint, tibiofemoral joint

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • extracapsular release of lateral retinaculumProcedure or surgery

    A new kind of surgery which releases the lateral retinaculum from outside the knee capsular, maintaining the structure of the knee capsular.

Study groups in NCT04977492
Study groupRoleWhat they receive
observation groupPeople suffered from excessive lateral pressure syndrome with extracapsular release of lateral retinaculum.
Receives: Procedure: extracapsular release of lateral retinaculum
control groupPeople suffered from excessive lateral pressure syndrome with conservative treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of lesions

    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.

    Measured: 2years

Secondary outcomes (2)
  1. Clinical symptom change

    Using Kujala score for symptom change.

    Measured: 2years

  2. Pain severity

    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.

    Measured: 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2018
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04977492
Sponsor's protocol ID
M2021082
Status last verified
Jul 2021
First submitted
27 Jun 2021
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Excessive Lateral Pressure Syndrome, run by Peking University Third Hospital.

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: stopped early, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early. 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?

Change of lesions (time frame: 2years). 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 27 Jul 2021.

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