Lateral Patellar SyndromeNCT06988930
To Compare the Clinical Efficacy of Arthroscopic Lateral Retinacular Release and Exercise Therapy in the Treatment of Lateral Patellar Crush Syndrome
A study of Lateral Patellar Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
One hundred patients with lateral patellar compression syndrome (LPCS) were recruited and divided into two groups: arthroscopic treatment group and rehabilitation conservative treatment group. A 2-year prospective cohort study was then conducted. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lateral Patellar Syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ① Meet the diagnostic criteria of LPCS; ② Complete imaging data; ③ agree that the follow-up time should be at least 1 Years; ④ Those who are willing to conduct regular rehabilitation training can cooperate to complete the experiment by signing the informed consent.
Who cannot join
- ① Complicated with severe heart, brain, kidney and other organ dysfunction;② Combined with patellar instability, patellar dislocation or others Severe knee joint disease and injury; ③ The previous history of joint infection, joint tuberculosis or osteomyelitis, or the lower extremity in 6 A history of surgery within the last month and previous knee surgery; ④ Infection, cancer, pregnancy and mental disorders Those with special conditions. ⑤ patients with mental illness or cognitive impairment, unable to study and participate in rehabilitation training; ⑥ not Informed consent was obtained.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
One hundred patients with lateral patellar compression syndrome (LPCS) were recruited and divided into two groups: arthroscopic treatment group and rehabilitation conservative treatment group. A 2-year prospective cohort study was then conducted. The subjective scores of 5 scales and 3 objective indexes were used to evaluate the recovery of knee joint function after different treatment methods, and to further clarify the medium and long-term therapeutic effects of different treatment methods on LPCS patients.
Read the detailed description
Lateral patellar over-compression syndrome is a musculoskeletal disease characterized by increased pressure on the lateral patellofemoral joint, which is caused by long-term tilting of the patella, adaptive contraction of the lateral retinaculum and long-term stress imbalance of the medial and lateral articular surfaces. The main clinical manifestations are patellofemoral joint pain, abnormal patellar trajectory and articular cartilage injury. At present, the prevalence of anterior knee pain is as high as 8. 5% ~ 17. 0%, and female is higher than male. LPCS has become one of the main causes of anterior knee pain . There are many methods for the treatment of LPCS, some of which are still controversial. At present, the gold standard for the treatment of LPCS has not been determined.
In the clinical practice of the Institute of Sports Medicine and the previous scientific research of our group, we found that a considerable number of patients, after arthroscopic patella molding, lateral retinaculum release and joint cleaning, their pain was obviously relieved, the patella trajectory almost returned to normal, and the knee joint symptoms were well improved and returned to normal life.
Both arthroscopic surgery and conservative rehabilitation can be used to treat LPCS, but it has not been proved that the functional improvement and symptom improvement rate of the two treatment methods are better in the medium and long term follow-up. Based on the above background, this study will conduct a prospective cohort study, and plan to recruit 100 patients and divide them into two groups, namely the arthroscopic group and the conservative treatment group, for a 2-year follow-up. The patients' subjective scores of 5 scales and 3 objective indicators were used to evaluate the recovery of knee function after different treatment methods, and to further clarify the medium and long-term therapeutic effects of different treatment methods on patients with LPCS, in order to provide guidance and reference for the clinical treatment of LPCS.
- Conditions
- Lateral Patellar Syndrome
- Being tested
- Control group
- Keywords
- lateral patellar compression syndrome, lateral retinacular release of the patella, patellofemoral joint rehabilitation, prospective cohort study, kinesitherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDiagnostic test
The non-operation group was treated with rehabilitation therapy for 6 weeks, and the operation group was treated with arthroscopic surgery and the pathological tissue of cartilage and subchondral bone was taken. Assessment was performed at three months, one year, and two years after treatment and recorded in the database.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group：arthroscopic surgery | Experimental | The patients with lateral patellar extrusion were treated with arthroscopic minimally invasive surgery. Receives: Diagnostic Test: Control group |
| Conservative rehabilitation training group | Active comparator | The patients in this group were treated with exercise therapy Receives: Diagnostic Test: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patellar axial X-ray
The degree of deviation of the patella was evaluated mainly by X-ray measurement
Measured: Before the intervention、3 months after the intervention and 1 year after the intervention
Secondary outcomes (3)
Visual Analogue Score
The Visual Analog Scale (VAS) is a tool used to assess pain or other subjective sensations. It is typically represented by a line segment, with one end indicating no pain or symptoms and the other end indicating the most severe pain or symptoms. In clinical research, the VAS is commonly used to evaluate the level of pain experienced by patients. Patients mark their pain level on a line segment that is marked from 0 to 10 , where 0 represents no pain and 10 represents the most severe pain.
Measured: Before the intervention、3 months after the intervention and 1 year after the intervention
Kujala score
The Kujala score is a system used to assess knee function. It quantifies pain, functional impairment, muscle strength, range of motion, swelling, and crepitus in the knee joint through a series of questions and examinations, thereby evaluating the overall condition of the knee. The score ranges from 0 to 100, with 100 being the highest possible score. A higher score indicates better knee function and less pain and functional impairment. Conversely, a lower score indicates severe knee dysfunction and significant pain and impairment. It is widely used in the diagnosis of knee-related diseases, evaluation of treatment outcomes, and rehabilitation guidance.
Measured: Before the intervention、3 months after the intervention and 1 year after the intervention
Lysholm knee score scale
The Lysholm knee score scale is mainly used to assess the functional recovery of the knee joint after injury or surgery and can also be applied in clinical research of knee joint diseases. It focuses on the patient's subjective feelings and ability to perform daily activities.
Measured: Before the intervention、3 months after the intervention and 1 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Patellar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT06988930
- Sponsor's protocol ID
- M2024181
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Clinical Efficacy of Arthroscopic Lateral Retinacular Release and Exercise Therapy in the Treatment of Lateral Patellar Crush Syndrome
- ClinicalTrials.gov ID
- NCT06988930
- Acronym / sponsor ID
- M2024181
- Conditions
- Lateral Patellar Syndrome
- Keywords
- lateral patellar compression syndrome, lateral retinacular release of the patella, patellofemoral joint rehabilitation, prospective cohort study, kinesitherapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 May 2025 (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.
One hundred patients with lateral patellar compression syndrome (LPCS) were recruited and divided into two groups: arthroscopic treatment group and rehabilitation conservative treatment group. A 2-year prospective cohort study was then conducted. The subjective scores of 5 scales and 3 objective indexes were used to evaluate the recovery of knee joint function after different treatment methods, and to further clarify the medium and long-term therapeutic effects of different treatment methods on LPCS patients.
Detailed description
Lateral patellar over-compression syndrome is a musculoskeletal disease characterized by increased pressure on the lateral patellofemoral joint, which is caused by long-term tilting of the patella, adaptive contraction of the lateral retinaculum and long-term stress imbalance of the medial and lateral articular surfaces. The main clinical manifestations are patellofemoral joint pain, abnormal patellar trajectory and articular cartilage injury. At present, the prevalence of anterior knee pain is as high as 8. 5% ~ 17. 0%, and female is higher than male. LPCS has become one of the main causes of anterior knee pain . There are many methods for the treatment of LPCS, some of which are still controversial. At present, the gold standard for the treatment of LPCS has not been determined.
In the clinical practice of the Institute of Sports Medicine and the previous scientific research of our group, we found that a considerable number of patients, after arthroscopic patella molding, lateral retinaculum release and joint cleaning, their pain was obviously relieved, the patella trajectory almost returned to normal, and the knee joint symptoms were well improved and returned to normal life.
Both arthroscopic surgery and conservative rehabilitation can be used to treat LPCS, but it has not been proved that the functional improvement and symptom improvement rate of the two treatment methods are better in the medium and long term follow-up. Based on the above background, this study will conduct a prospective cohort study, and plan to recruit 100 patients and divide them into two groups, namely the arthroscopic group and the conservative treatment group, for a 2-year follow-up. The patients' subjective scores of 5 scales and 3 objective indicators were used to evaluate the recovery of knee function after different treatment methods, and to further clarify the medium and long-term therapeutic effects of different treatment methods on patients with LPCS, in order to provide guidance and reference for the clinical treatment of LPCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group：arthroscopic surgery | Experimental | Diagnostic Test: Control groupThe patients with lateral patellar extrusion were treated with arthroscopic minimally invasive surgery. |
| Conservative rehabilitation training group | Active comparator | Diagnostic Test: Control groupThe patients in this group were treated with exercise therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ① Meet the diagnostic criteria of LPCS; ② Complete imaging data; ③ agree that the follow-up time should be at least 1 Years; ④ Those who are willing to conduct regular rehabilitation training can cooperate to complete the experiment by signing the informed consent.
Key exclusion criteria (1 listed)
- ① Complicated with severe heart, brain, kidney and other organ dysfunction;② Combined with patellar instability, patellar dislocation or others Severe knee joint disease and injury; ③ The previous history of joint infection, joint tuberculosis or osteomyelitis, or the lower extremity in 6 A history of surgery within the last month and previous knee surgery; ④ Infection, cancer, pregnancy and mental disorders Those with special conditions. ⑤ patients with mental illness or cognitive impairment, unable to study and participate in rehabilitation training; ⑥ not Informed consent was obtained.
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 |
|---|---|---|
| Control groupThe non-operation group was treated with rehabilitation therapy for 6 weeks, and the operation group was treated with arthroscopic surgery and the pathological tissue of cartilage and subchondral bone was taken. Assessment was performed at three months, one year, and two years after treatment and recorded in the database. | Diagnostic test | Conservative rehabilitation training group, Experimental group：arthroscopic surgery |
Primary outcome
Patellar axial X-ray
Time frame: Before the intervention、3 months after the intervention and 1 year after the intervention
The degree of deviation of the patella was evaluated mainly by X-ray measurement
3 secondary outcomes
Visual Analogue Score
Time frame: Before the intervention、3 months after the intervention and 1 year after the intervention
Kujala score
Time frame: Before the intervention、3 months after the intervention and 1 year after the intervention
Lysholm knee score scale
Time frame: Before the intervention、3 months after the intervention and 1 year after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes
Related trials for Lateral Patellar Syndrome
Recruiting
Compressive Myofascial Release of the Vastus Lateralis on Lateral Patellar Tracking in Patellofemoral Pain Syndrome
Patellofemoral Pain Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lateral Patellar Syndrome, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 25 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patellar axial X-ray (time frame: Before the intervention、3 months after the intervention and 1 year after the intervention). 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 25 May 2025.