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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

NCT04556799 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-21

No results posted yet for this study

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

Conditions

  • Recurrent Patellar Dislocation
  • Osteotomy
  • Patellar Maltracking

Interventions

PROCEDURE

computer-assisted surgery

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

PROCEDURE

traditional osteotomy

traditional osteotomy without the aid of 3D osteotomy template

Sponsors & Collaborators

  • Beijing Jishuitan Hospital

    lead OTHER

Principal Investigators

  • Hui Zhang · Sports Medicine Service, Beijing Jishuitan hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-30
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556799 on ClinicalTrials.gov