Back to resultsArthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ACL Repair
ACL Reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries
Eligibility Criteria
Inclusion Criteria:
- Patients with anterior cruciate ligament tear clearly identified by imaging or intraoperative microscope, Sherman grade I, II; planned surgery within 3 weeks after injury
- Basic reading and writing skills, and barrier-free communication
- A smartphone, can use WeChat or be able to learn
- Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP
Exclusion Criteria:
- Combined with other knee joint injuries (posterior cruciate ligament injury, patellar dislocation, osteoarthritis, etc.)
- Suffering from systemic immune diseases;
- Existing other knee joint diseases or inflammatory diseases, including osteoarthritis, cervical spine disease, rheumatoid arthritis, fibromyalgia, polymyalgia rheumatica, etc.
- Patients who have received local hormone injection within 3 months;
- Those who have participated in clinical trials or are undergoing other clinical trials within 3 months before screening
- Those who have serious primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that they are not suitable for selection
- Patients with severe liver disease, kidney disease, and hematological disease, such as renal function exceeding the upper limit of the normal value, and liver function exceeding 2 times the upper limit of the normal value;
- Suffering from viral hepatitis, infectious diseases, severe abnormal blood coagulation mechanism and other Diseases that the researchers consider inappropriate for surgery
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the follow-up period, those who have a positive urine human chorionic gonadotropin test result before sampling; menstruating women should wait until the end of menstruation before surgery;
- Severe neurological and mental disorders Disease patients;
- Suspected or actual history of alcohol and drug abuse.
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ACL Repair
ACL Reconstruction
Arm Description
Patients under surgical anterior cruciate ligament repair
Patients under surgical anterior cruciate ligament reconstruction
Outcomes
Primary Outcome Measures
IKDC score
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Efficiency of 1 year after operation=Sum of Items/Maximum Possible Score *100
Secondary Outcome Measures
IKDC score
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Efficiency of 3 months after operation=Sum of Items/Maximum Possible Score *100
IKDC score
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Efficiency of 6 months after operation=Sum of Items/Maximum Possible Score *100
IKDC score
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Efficiency of 2 years after operation=Sum of Items/Maximum Possible Score *100
Full Information
NCT ID
NCT05584020
First Posted
October 13, 2022
Last Updated
October 16, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05584020
Brief Title
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury
Official Title
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury: a Multicenter Randomized Controlled Surgical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Background: Arthroscopic anterior cruciate ligament(ACL) reconstruction is so far the gold standard for the treatment of ACL ruptures, but this technique still suffers from problems of tendon-bone healing, bone tunnel enlargement, bone resorption, a low rate of return to motion,etc. In recent years, due to the innovation of medical materials and surgical techniques, anterior cruciate ligament repair technology has returned to the field of vision of clinical doctors. This technique has the advantages of preserving the natural ligaments and their proprioceptive sensation, avoiding the bone injury of the tunnel and the complications of the donor site. However, there is still a lack of high-quality clinical randomized controlled trails to provide evidence of the effect of arthroscopic ACL repair.
Hypothesis: Arthroscopic ACL repair is comparable to ACL reconstruction in patients with ACL tears (Sherman grades I and II).
Study Design: This study was a prospective, multicenter, randomized, double-blinded, parallel-controlled, non-inferiority trial design. A total of 330 patients with ACL tears were randomly divided into 2 groups, and were randomly assigned to the experimental group (arthroscopic anterior cruciate ligament repair) and the control group (arthroscopic anterior cruciate ligament reconstruction) according to 1:1. Follow-up knee function and other scores were performed at 3 months, 6 months, 1 year, and 2 years after surgery, and the total study time is expected to be 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACL Repair
Arm Type
Experimental
Arm Description
Patients under surgical anterior cruciate ligament repair
Arm Title
ACL Reconstruction
Arm Type
Other
Arm Description
Patients under surgical anterior cruciate ligament reconstruction
Intervention Type
Procedure
Intervention Name(s)
ACL Repair
Intervention Description
Patients are undergoing arthroscopic anterior cruciate ligament repair. The native ACL is repaired using very strong sutures. This device is used to repair the native ACL and restore knee stability.
Intervention Type
Procedure
Intervention Name(s)
ACL Reconstruction
Intervention Description
Patients are undergoing arthroscopic anterior cruciate ligament reconstruction. The torn ligament is removed and replaced with a band of tissue that usually connects muscle to bone. The graft tendon is taken from another part of your knee or from a deceased donor.
Primary Outcome Measure Information:
Title
IKDC score
Description
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Efficiency of 1 year after operation=Sum of Items/Maximum Possible Score *100
Time Frame
1 year
Secondary Outcome Measure Information:
Title
IKDC score
Description
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Efficiency of 3 months after operation=Sum of Items/Maximum Possible Score *100
Time Frame
3 months
Title
IKDC score
Description
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Efficiency of 6 months after operation=Sum of Items/Maximum Possible Score *100
Time Frame
6 months
Title
IKDC score
Description
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Efficiency of 2 years after operation=Sum of Items/Maximum Possible Score *100
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with anterior cruciate ligament tear clearly identified by imaging or intraoperative microscope, Sherman grade I, II; planned surgery within 3 weeks after injury
Basic reading and writing skills, and barrier-free communication
A smartphone, can use WeChat or be able to learn
Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP
Exclusion Criteria:
Combined with other knee joint injuries (posterior cruciate ligament injury, patellar dislocation, osteoarthritis, etc.)
Suffering from systemic immune diseases;
Existing other knee joint diseases or inflammatory diseases, including osteoarthritis, cervical spine disease, rheumatoid arthritis, fibromyalgia, polymyalgia rheumatica, etc.
Patients who have received local hormone injection within 3 months;
Those who have participated in clinical trials or are undergoing other clinical trials within 3 months before screening
Those who have serious primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that they are not suitable for selection
Patients with severe liver disease, kidney disease, and hematological disease, such as renal function exceeding the upper limit of the normal value, and liver function exceeding 2 times the upper limit of the normal value;
Suffering from viral hepatitis, infectious diseases, severe abnormal blood coagulation mechanism and other Diseases that the researchers consider inappropriate for surgery
Women who are pregnant or breastfeeding, or who plan to become pregnant during the follow-up period, those who have a positive urine human chorionic gonadotropin test result before sampling; menstruating women should wait until the end of menstruation before surgery;
Severe neurological and mental disorders Disease patients;
Suspected or actual history of alcohol and drug abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuesong Dai, Doctor
Phone
+8613777882818
Email
daixshz@163.com
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuesong Dai, Doctor
Phone
+8613777882818
12. IPD Sharing Statement
Learn more about this trial
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury
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