NCT04556799

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

Status unknown NA Last updated 21 September 2020

What this trial tests

NA trial testing computer-assisted surgery in Recurrent Patellar Dislocation in 50 participants. Status unknown.

Timeline

1 October 2020

Primary endpoint
30 June 2022

30 June 2023

Quick facts

Lead sponsor	Beijing Jishuitan Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	1 October 2020
Primary completion	30 June 2022
Estimated completion	30 June 2023

Drugs / interventions tested

• computer-assisted surgery
• traditional osteotomy

Conditions studied

• Recurrent Patellar Dislocation — all drugs for Recurrent Patellar Dislocation →
• Osteotomy — all drugs for Osteotomy →
• Patellar Maltracking — all drugs for Patellar Maltracking →

Sponsor

Beijing Jishuitan Hospital

Who can join

14 and older, any sex, with Recurrent Patellar Dislocation or Osteotomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.