Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy

September 15, 2020 updated by: Hui Zhang
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
underwent "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
Procedure: Four-in-one procedure
"four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement"
Placebo Comparator: Control group
traditional soft tissue surgery
Procedure: soft-tissue surgery
traditional soft-tissue surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kujala score
Time Frame: 1 year postoperatively
A functional score used to assess the knee function
1 year postoperatively
quadriceps strength
Time Frame: 1 year postoperatively
quantify the quadriceps strength using Biodex®
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Zhang

Investigators

  • Study Director: Hui Zhang, Sports Medicine Service, Beijing Jishuitan hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • HuiZ-2

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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