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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04556812
Other study ID # HuiZ-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date June 30, 2023

Study information

Verified date September 2020
Source Beijing Jishuitan Hospital
Contact Zhijun Zhang, M.D.
Phone +86 15201277648
Email zzj5285029@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adult habitual dislocation of the patella is a common dislocation of the patella. The range of lesions is wide and the severity is high. Clinical diagnosis and treatment are difficult. In clinical work, misdiagnosis and treatment are not targeted at pathological mechanisms. This leads to irregular diagnosis and treatment, high failure rate and revision rate, and patients undergoing multiple operations. The project team developed a "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement" in the preliminary research, which overcomes the disadvantages of traditional knee extension surgery and is suitable for adults. Early research Shows safe and effective clinical efficacy. The purpose of this application project is to take independent innovation of core surgical technology as the lead, adopt a two-way cohort study method, compare the clinical efficacy of the new "four-in-one" technology and traditional soft tissue surgery in the treatment of adult habitual patellar dislocation, and analyze and formulate adult habituation Comprehensive and systematic solutions for patella dislocation, relying on this scientific research project to conduct multi-center and large-sample clinical case studies, and evaluate the effectiveness and safety of independent innovative technologies through standardized medical research methods to improve the surgical treatment of adult habitual patella dislocation Success rate, reduce recurrence rate and failure rate, improve the level of clinical treatment of the disease, and finally put forward a special clinical diagnosis and treatment system for the disease in the international academic community.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date June 30, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria:

- Patients with habitual dislocation of the patella over 14 years old

- agree to participate in the study

Exclusion Criteria:

- Combined with other knee ligament injuries

- recurrent patellar dislocation

- Skin and soft tissue conditions do not allow surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Four-in-one procedure
"four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
soft-tissue surgery
traditional soft-tissue surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hui Zhang

Outcome

Type Measure Description Time frame Safety issue
Primary Kujala score A functional score used to assess the knee function 1 year postoperatively
Primary quadriceps strength quantify the quadriceps strength using Biodex® 1 year postoperatively