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

NCT ID: NCT04556812

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-06-30

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.

Detailed Description

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Conditions

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Habitual Patellar Dislocation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

underwent "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"

Group Type EXPERIMENTAL

Four-in-one procedure

Intervention Type PROCEDURE

"four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"

Control group

traditional soft tissue surgery

Group Type PLACEBO_COMPARATOR

soft-tissue surgery

Intervention Type PROCEDURE

traditional soft-tissue surgery

Interventions

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Four-in-one procedure

"four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"

Intervention Type PROCEDURE

soft-tissue surgery

traditional soft-tissue surgery

Intervention Type PROCEDURE

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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hui Zhang

OTHER

Sponsor Role lead

Responsible Party

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Hui Zhang

Doctor of Sports Medicine Service of Beijing Jishuitan hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hui Zhang

Role: STUDY_DIRECTOR

Sports Medicine Service, Beijing Jishuitan hospital

Central Contacts

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Zhijun Zhang, M.D.

Role: CONTACT

+86 15201277648

Other Identifiers

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HuiZ-2

Identifier Type: -

Identifier Source: org_study_id

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