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Status unknownNCT04556799Updated Sep 21, 2020

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

An interventional study of computer-assisted surgery and traditional osteotomy in Recurrent Patellar Dislocation, Osteotomy and Patellar Maltracking, sponsored by Beijing Jishuitan Hospital. Status unknown. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2020-09-21.

Sponsored by Beijing Jishuitan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

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

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Conditions studied

  • Recurrent Patellar Dislocation
  • Osteotomy
  • Patellar Maltracking

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03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 22 interventional studies indexed under Patellar Dislocation.

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Lead sponsor

Beijing Jishuitan Hospital is the lead sponsor of 44 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Study group

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

    Procedure: computer-assisted surgery

  • Experimental
    Control group

    traditional osteotomy technique

    Procedure: traditional osteotomy

Interventions

  • Procedurecomputer-assisted surgery

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

  • Proceduretraditional osteotomy

    traditional osteotomy without the aid of 3D osteotomy template

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What researchers measure

Primary outcomes

  1. Lysholm score

    A function score to assess the knee function

    Time frame: 1 year postoperatively

  2. quadriceps strength

    to assess the postoperative quadriceps strength using Biodex®

    Time frame: 1 year postoperatively

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04556799
Lead sponsor
Beijing Jishuitan Hospital
Responsible party
Hui Zhang (Doctor of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan Hospital) — Principal investigator
First posted
Sep 21, 2020
Start date
Oct 1, 2020 (estimated)
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Sep 21, 2020

Study contacts

Zhijun Zhang, M.D.
Contact
zzj5285029@163.com
+86 15201277648
Hui Zhang
principal investigator · Sports Medicine Service, Beijing Jishuitan hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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