Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy

Study Overview
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Brief Summary
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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.

Official Title
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Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy

Conditions
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Habitual Patellar Dislocation

Intervention / Treatment
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* Procedure: Four-in-one procedure
* Procedure: soft-tissue surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>underwent four-in-one surgical technique centered on tibial tuberosity osteotomy and proximal displacement | Procedure: Four-in-one procedure<br>* four-in-one surgical technique centered on tibial tuberosity osteotomy and proximal displacement<br>|
| Placebo Comparator: Control group<br>traditional soft tissue surgery | Procedure: soft-tissue surgery<br>* traditional soft-tissue surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kujala score | A functional score used to assess the knee function | 1 year postoperatively | 
| quadriceps strength | quantify the quadriceps strength using Biodex® | 1 year postoperatively |