Recurrent Patellar DislocationNCT04456881
Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament
A study testing Patients with patellar dislocation undergo patellar femoral medial reconstruction in people with Recurrent Patellar Dislocation, run by Peking University Third Hospital at 1 site in China.
Trial summary
Objective: To study the clinical effect of double-beam anatomical reconstruction of medial patellofemoral ligament under arthroscopy. Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was performed under arthroscopy in patients admitted to our hospital for treatment of recurrent patellar… Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Recurrent Patellar Dislocation
- What is being tested?
- Patients with patellar dislocation undergo patellar femoral medial reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 May 2024
- Phase
- Interventional
- 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 17 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 17<age<60 years
- Recurrent patellar dislocation or instability
Who cannot join
- Bone spurs or bone protrusions on the D-type of the femoral pulley or proximal of the pulley.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Beijing, Beijing Municipality, 100191
Ping Liu
About this study
Objective: To study the clinical effect of double-beam anatomical reconstruction of medial patellofemoral ligament under arthroscopy.
Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was performed under arthroscopy in patients admitted to our hospital for treatment of recurrent patellar dislocation. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.
Read more
Expected results: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament can effectively restore the stability of the patella and the motor function of the knee joint.
Expected conclusion: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament is an effective minimally invasive technique.
Keywords: knee joint; medial patellofemoral ligament; double-beam anatomical reconstruction; arthroscopy
- Conditions
- Recurrent Patellar Dislocation
- Being tested
- Patients with patellar dislocation undergo patellar femoral medial reconstruction
- Keywords
- arthroscopy, medial patellofemoral ligament
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with patellar dislocation undergo patellar femoral medial reconstructionOther
Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament
| Study group | Role | What they receive |
|---|---|---|
| anatomical reconstruction group of Patellofemoral ligament | Experimental | Not described Receives: Other: Patients with patellar dislocation undergo patellar femoral medial reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score
The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
Measured: 1 year after operation
International Knee Documentation Committee (IKDC) 2000
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
Measured: 1 year after operation
Tegner activity level score
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Patellar DislocationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04456881
- Sponsor's protocol ID
- 2014205
- Status last verified
- Jan 2023
- First submitted
- 27 Jun 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament
- ClinicalTrials.gov ID
- NCT04456881
- Acronym / sponsor ID
- 2014205
- Conditions
- Recurrent Patellar Dislocation
- Keywords
- arthroscopy, medial patellofemoral ligament
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 7 Jul 2020 (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.
Objective: To study the clinical effect of double-beam anatomical reconstruction of medial patellofemoral ligament under arthroscopy.
Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was performed under arthroscopy in patients admitted to our hospital for treatment of recurrent patellar dislocation. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.
Expected results: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament can effectively restore the stability of the patella and the motor function of the knee joint.
Expected conclusion: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament is an effective minimally invasive technique.
Keywords: knee joint; medial patellofemoral ligament; double-beam anatomical reconstruction; arthroscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anatomical reconstruction group of Patellofemoral ligament | Experimental | Other: Patients with patellar dislocation undergo patellar femoral medial reconstruction |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 17<age<60 years
- Recurrent patellar dislocation or instability
Key exclusion criteria (1 listed)
- Bone spurs or bone protrusions on the D-type of the femoral pulley or proximal of the pulley.
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 |
|---|---|---|
| Patients with patellar dislocation undergo patellar femoral medial reconstructionArthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament | Other | anatomical reconstruction group of Patellofemoral ligament |
Primary outcome
Lysholm score
Time frame: 1 year after operation
The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
International Knee Documentation Committee (IKDC) 2000
Time frame: 1 year after operation
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
Tegner activity level score
Time frame: 1 year after operation
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Recurrent Patellar Dislocation
Not yet recruiting
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
Recurrent Patellar Displacement, MPFL
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
Recruiting
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
Patellar Instability
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with patellar dislocation undergo patellar femoral medial reconstruction in people with Recurrent Patellar Dislocation, 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 2 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Liu (13683670396, bjusmlp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm score (time frame: 1 year after operation). The study lists 3 primary outcomes in all. 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 18 Apr 2023.