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
About this trial
This is an interventional treatment trial for Recurrent Patellar Dislocation
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
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
NCT ID
NCT04556799
First Posted
September 15, 2020
Last Updated
September 15, 2020
Sponsor
Beijing Jishuitan Hospital
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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