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

Not Applicable

• Conditions: Habitual Patellar Dislocation
• Interventions: Procedure: Four-in-one procedure; Procedure: soft-tissue surgery

• Registration Number: NCT04556812
• Lead Sponsor: Hui Zhang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21
• Study Start: 2020-10-01
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Four-in-one procedure	underwent "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
Control group	soft-tissue surgery	traditional soft tissue surgery

Primary Outcome Measures

Name	Time	Method
quadriceps strength	1 year postoperatively	quantify the quadriceps strength using Biodex®
Kujala score	1 year postoperatively	A functional score used to assess the knee function