Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
Primary Purpose
Habitual Patellar Dislocation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Four-in-one procedure
soft-tissue surgery
Sponsored by
About this trial
This is an interventional treatment trial for Habitual Patellar Dislocation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study group
Control group
Arm Description
underwent "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
traditional soft tissue surgery
Outcomes
Primary Outcome Measures
Kujala score
A functional score used to assess the knee function
quadriceps strength
quantify the quadriceps strength using Biodex®
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04556812
Brief Title
Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
Official Title
Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hui Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Habitual Patellar Dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
underwent "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
traditional soft tissue surgery
Intervention Type
Procedure
Intervention Name(s)
Four-in-one procedure
Intervention Description
"four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
Intervention Type
Procedure
Intervention Name(s)
soft-tissue surgery
Intervention Description
traditional soft-tissue surgery
Primary Outcome Measure Information:
Title
Kujala score
Description
A functional score used to assess the knee function
Time Frame
1 year postoperatively
Title
quadriceps strength
Description
quantify the quadriceps strength using Biodex®
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhijun Zhang, M.D.
Phone
+86 15201277648
Email
zzj5285029@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhang
Organizational Affiliation
Sports Medicine Service, Beijing Jishuitan hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
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