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

NCT04556799 | Unknown

• 1 other identifier: HuiZ
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Recurrent Patellar Dislocation; Osteotomy; Patellar Maltracking

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Study group

EXPERIMENTAL

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

Procedure: computer-assisted surgery

Control group

EXPERIMENTAL

traditional osteotomy technique

Procedure: traditional osteotomy

Interventions

computer-assisted surgery PROCEDURE

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

Study group

traditional osteotomy PROCEDURE

traditional osteotomy without the aid of 3D osteotomy template

Control group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

MeSH Terms

Conditions

Patellar Dislocation

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Hui Zhang

  Sports Medicine Service, Beijing Jishuitan hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijun Zhang, M.D.

CONTACT

+86 15201277648; zzj5285029@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Sports Medicine Service of Beijing Jishuitan hospital

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share