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.
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.
- Conditions
- Excessive Lateral Pressure Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| observation group | People suffered from excessive lateral pressure syndrome with extracapsular release of lateral retinaculum. Receives: Procedure: extracapsular release of lateral retinaculum | |
| control group | People 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.
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)
Clinical symptom change
Using Kujala score for symptom change.
Measured: 2years
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.
- First posted27 Jul 2021
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Lateral Pressure SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Study of Excessive Lateral Pressure Syndrome
- ClinicalTrials.gov ID
- NCT04977492
- Acronym / sponsor ID
- M2021082
- Conditions
- Excessive Lateral Pressure Syndrome
- Keywords
- excessive lateral pressure syndrome, patellofemoral joint, tibiofemoral joint
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 27 Jul 2021 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Procedure: extracapsular release of lateral retinaculumPeople suffered from excessive lateral pressure syndrome with extracapsular release of lateral retinaculum. |
| control group | – | –People suffered from excessive lateral pressure syndrome with conservative treatment. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young and middle-aged sports active people
Key inclusion criteria (2 listed)
- Age <40.
- Normal lower limb strength line: no valgus or varus feet, no hyperpronation of hind feet, negative J sign.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| extracapsular release of lateral retinaculumA new kind of surgery which releases the lateral retinaculum from outside the knee capsular, maintaining the structure of the knee capsular. | Procedure or surgery | observation group |
Primary outcome
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.
2 secondary outcomes
Clinical symptom change
Time frame: 2years
Pain severity
Time frame: 2years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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.