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

Primary Purpose

Habitual Patellar Dislocation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Four-in-one procedure
soft-tissue surgery
Sponsored by
Hui Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Habitual Patellar Dislocation

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Study group

    Control group

    Arm Description

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

    traditional soft tissue surgery

    Outcomes

    Primary Outcome Measures

    Kujala score
    A functional score used to assess the knee function
    quadriceps strength
    quantify the quadriceps strength using Biodex®

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2020
    Last Updated
    September 15, 2020
    Sponsor
    Hui Zhang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04556812
    Brief Title
    Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
    Official Title
    Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hui Zhang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Habitual Patellar Dislocation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    underwent "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    traditional soft tissue surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Four-in-one procedure
    Intervention Description
    "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
    Intervention Type
    Procedure
    Intervention Name(s)
    soft-tissue surgery
    Intervention Description
    traditional soft-tissue surgery
    Primary Outcome Measure Information:
    Title
    Kujala score
    Description
    A functional score used to assess the knee function
    Time Frame
    1 year postoperatively
    Title
    quadriceps strength
    Description
    quantify the quadriceps strength using Biodex®
    Time Frame
    1 year postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhijun Zhang, M.D.
    Phone
    +86 15201277648
    Email
    zzj5285029@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hui Zhang
    Organizational Affiliation
    Sports Medicine Service, Beijing Jishuitan hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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