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Status unknownNCT04983992Updated Jul 30, 2021

Prospective Clinical Study of Excessive Lateral Pressure Syndrome

An observational study in Excessive Lateral Pressure Syndrome, sponsored by Peking University Third Hospital. Status unknown. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-07-30.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
10 Years to 40 Years
Sex
All
01

Study summary

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.

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 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.

02

Conditions studied

  • Excessive Lateral Pressure Syndrome

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Keywords

  • excessive lateral pressure syndrome
  • patellofemoral joint
  • tibiofemoral joint
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 200 is above the median of 102 across 2,209 observational studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Young and middle-aged sports active people

Eligibility criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • observation group

    People suffered from excessive lateral pressure syndrome with extracapsular release of lateral retinaculum.

    Procedure: extracapsular release of lateral retinaculum

  • control group

    People suffered from excessive lateral pressure syndrome with conservative treatment

Interventions

  • Procedureextracapsular 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 2years

Secondary outcomes

  1. Pain severity change

    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.

    Time frame: 2years

  2. Clinical symptom change

    Using Kujala score for symptom change.

    Time frame: 2years

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04983992
Lead sponsor
Peking University Third Hospital
Collaborators
Weihai Wendeng District Central Hospital, Inner Mongolia Autonomous Region Hospital, Beijing Delconi Orthopaedic Hospital
Responsible party
Sponsor
First posted
Jul 30, 2021
Start date
Sep 1, 2021 (estimated)
Primary completion
Jul 1, 2022 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Jul 30, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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