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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Patellar Dislocation; Osteotomy; Patellar Maltracking
• Intervention / Treatment: Procedure: computer-assisted surgery; Procedure: traditional osteotomy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group; 3D osteotomy template for derotation osteotomy with the aid of computer-assisted simulated surgery technique	Procedure: computer-assisted surgery; derotation osteotomy with the aid of 3D osteotomy template and computer-assisted simulated surgery
EXPERIMENTAL: Control group; traditional osteotomy technique	Procedure: traditional osteotomy; traditional osteotomy without the aid of 3D osteotomy template

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm score	A function score to assess the knee function	1 year postoperatively
quadriceps strength	to assess the postoperative quadriceps strength using Biodex®	1 year postoperatively

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Principal Investigator: Hui Zhang, Sports Medicine Service, Beijing Jishuitan hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (ACTUAL): September 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Recurrence; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: HuiZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No