- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556812
Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
September 15, 2020 updated by: Hui Zhang
Adult habitual dislocation of the patella is a common dislocation of the patella.
The range of lesions is wide and the severity is high.
Clinical diagnosis and treatment are difficult.
In clinical work, misdiagnosis and treatment are not targeted at pathological mechanisms.
This leads to irregular diagnosis and treatment, high failure rate and revision rate, and patients undergoing multiple operations.
The project team developed a "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement" in the preliminary research, which overcomes the disadvantages of traditional knee extension surgery and is suitable for adults.
Early research Shows safe and effective clinical efficacy.
The purpose of this application project is to take independent innovation of core surgical technology as the lead, adopt a two-way cohort study method, compare the clinical efficacy of the new "four-in-one" technology and traditional soft tissue surgery in the treatment of adult habitual patellar dislocation, and analyze and formulate adult habituation Comprehensive and systematic solutions for patella dislocation, relying on this scientific research project to conduct multi-center and large-sample clinical case studies, and evaluate the effectiveness and safety of independent innovative technologies through standardized medical research methods to improve the surgical treatment of adult habitual patella dislocation Success rate, reduce recurrence rate and failure rate, improve the level of clinical treatment of the disease, and finally put forward a special clinical diagnosis and treatment system for the disease in the international academic community.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with habitual dislocation of the patella over 14 years old
- agree to participate in the study
Exclusion Criteria:
- Combined with other knee ligament injuries
- recurrent patellar dislocation
- Skin and soft tissue conditions do not allow surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
underwent "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
|
"four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
|
Placebo Comparator: Control group
traditional soft tissue surgery
|
traditional soft-tissue surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kujala score
Time Frame: 1 year postoperatively
|
A functional score used to assess the knee function
|
1 year postoperatively
|
quadriceps strength
Time Frame: 1 year postoperatively
|
quantify the quadriceps strength using Biodex®
|
1 year postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hui Zhang, Sports Medicine Service, Beijing Jishuitan hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 15, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HuiZ-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Habitual Patellar Dislocation
-
Finnish Defense ForcesTampere University HospitalTerminatedPatellofemoral Osteoarthritis | Patellar Instability | Patella-DislocationFinland
-
Hospices Civils de LyonActive, not recruitingEpisodic Patellar DislocationFrance
-
Polish Mother Memorial Hospital Research InstituteCompletedThe Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.Recurrent Patellar Dislocation | Patellar InstabilityPoland
-
Beijing Jishuitan HospitalNot yet recruitingRecurrent Patellar Dislocation | Osteotomy | Patellar Maltracking
-
Artromedical Konrad Malinowski ClinicRecruitingLateral Patellofemoral Dislocation Closed Traumatic | Lateral Patellar LuxationPoland
-
Polish Mother Memorial Hospital Research InstituteCompletedPatellofemoral Osteoarthritis | Recurrent Patellar Dislocation | Patellar InstabilityPoland
-
Radboud University Medical CenterRecruitingPatellar Dislocation | Patellofemoral Maltracking | Patellar Dislocation, RecurrentNetherlands
-
Peking University Third HospitalRecruitingRecurrent Patellar DislocationChina
-
Ramsay Générale de SantéEuropean Clinical Trial Experts Network; Dr Vincent ChassaingCompletedPatellar Dislocation | Patellar InstabilityFrance
-
Hannover Medical SchoolCompletedPatellar Instability | Patellar LuxationGermany
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Frequency TherapeuticsCompletedSensorineural Hearing Loss | Noise Induced Hearing Loss | Sudden Sensorineural Hearing LossUnited States
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