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The Clinical Results of Derotational Osteotomy Based on 3D Osteotomy Template for Treatment of Recurrent Patellar Dislocation Combined With Patellofemoral Maltracking

Primary Purpose

Recurrent Patellar Dislocation, Osteotomy, Patellar Maltracking

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
computer-assisted surgery
traditional osteotomy
Sponsored by
Beijing Jishuitan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Patellar Dislocation

Eligibility Criteria

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

Inclusion Criteria:

  • patients with recurrent patellar dislocation
  • >14 years old
  • positive preoperative J-sign
  • agree to participate the study

Exclusion Criteria:

  • Combined with other ligament injuries of knee joint
  • Skin and soft tissue conditions do not permit surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Study group

    Control group

    Arm Description

    3D osteotomy template for derotation osteotomy with the aid of computer-assisted simulated surgery technique

    traditional osteotomy technique

    Outcomes

    Primary Outcome Measures

    Lysholm score
    A function score to assess the knee function
    quadriceps strength
    to assess the postoperative quadriceps strength using Biodex®

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2020
    Last Updated
    September 15, 2020
    Sponsor
    Beijing Jishuitan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04556799
    Brief Title
    The Clinical Results of Derotational Osteotomy Based on 3D Osteotomy Template for Treatment of Recurrent Patellar Dislocation Combined With Patellofemoral Maltracking
    Official Title
    The Clinical Results of Derotational Osteotomy Based on 3D Osteotomy Template for Treatment of Recurrent Patellar Dislocation Combined With Patellofemoral Maltracking
    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
    Principal Investigator
    Name of the Sponsor
    Beijing Jishuitan Hospital

    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
    For severe recurrent patellar dislocation with poor patellar maltracking, derotation osteotomy is an effective clinical treatment. However, derotation osteotomy requires very high requirements for the surgeon. It is necessary to determine the osteotomy surface, control the axis and complete internal fixation in three dimensions. The deviation of the osteotomy surface may cause deformities such as postoperative knee valgus, knee hyperextension, or restricted extension. The hypothesis of this study is to design a 3D osteotomy template for derotation osteotomy with the aid of computer-assisted simulated surgery. Compared with traditional osteotomy, it can effectively improve the treatment effect of recurrent patellar dislocation due to poor patellar maltracking. The incidence of postoperative knee valgus shortens the operation time and reduces the number of intraoperative fluoroscopy. This study intends to adopt a randomized controlled study, and the selection criteria are adolescent patients with recurrent patellar dislocation, aged >14 years, with a positive J sign. The experimental group used mimics 20.0 software to reconstruct the three-dimensional model of the patient based on the full-length images of the lower limbs in the weight-bearing position and the CT of the hip, knee and ankle before the operation. The osteotomy template was designed and 3D printing technology was used to make the osteotomy template for intraoperative osteotomy. The control group used traditional de-rotation techniques. The knee joint range of motion, patella stability, residual rate of J-sign, knee valgus angle, femoral anteversion angle, gait analysis, etc. were compared between the two groups after surgery, and the differences between the two surgical techniques were evaluated

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Patellar Dislocation, Osteotomy, Patellar Maltracking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    3D osteotomy template for derotation osteotomy with the aid of computer-assisted simulated surgery technique
    Arm Title
    Control group
    Arm Type
    Experimental
    Arm Description
    traditional osteotomy technique
    Intervention Type
    Procedure
    Intervention Name(s)
    computer-assisted surgery
    Intervention Description
    derotation osteotomy with the aid of 3D osteotomy template and computer-assisted simulated surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    traditional osteotomy
    Intervention Description
    traditional osteotomy without the aid of 3D osteotomy template
    Primary Outcome Measure Information:
    Title
    Lysholm score
    Description
    A function score to assess the knee function
    Time Frame
    1 year postoperatively
    Title
    quadriceps strength
    Description
    to assess the postoperative 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 recurrent patellar dislocation >14 years old positive preoperative J-sign agree to participate the study Exclusion Criteria: Combined with other ligament injuries of knee joint Skin and soft tissue conditions do not permit 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
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Clinical Results of Derotational Osteotomy Based on 3D Osteotomy Template for Treatment of Recurrent Patellar Dislocation Combined With Patellofemoral Maltracking

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