Status:
NOT_YET_RECRUITING
Reverse Drilling Technique in Improving Outcomes After Arthroscopic Anterior Cruciate Ligament Reconstruction
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Ningbo Medical Center Lihuili Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Conditions:
Anterior Cruciate Ligament Injuries
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Anterior cruciate ligament (ACL) injuries and bone tunnel enlargement (BTE) after ACL reconstruction (ACLR) remain frequent issues. Bone dust (BD) produced by tunnel preparation with osteogenic abilit...
Detailed Description
Compaction technique can create a denser bone tunnel wall with more cancellous bone autografting in situ by sequentially compressing cancellous bone trabeculae to bone tunnel walls, in contrast to con...
Eligibility Criteria
Inclusion
- Patients with definite anterior cruciate ligament injuries on imaging or intraoperative arthroscopy (Sherman grading II and III), plan surgery within 45 days from injury; have basic literacy skills and unimpeded communication; have a smartphone and are able to use WeChat; and have been given informed consent and have signed to obtain an informed consent form, and the process must be in accordance with GCP requirements.
Exclusion
- 1\) Combined with other knee injuries (posterior cruciate ligament injury, patellar dislocation, osteoarthritis, etc.); 2) Suffering from systemic immune diseases; 3) Presence of other diseases or inflammatory diseases of the knee, including osteoarthritis, cervical spondylosis, rheumatoid arthritis, fibromyalgia, and rheumatic polymyalgia, etc.; 4) Patients who have had localized hormone injection therapy within 3 months; 5) Those who have participated in a clinical trials or are undergoing other clinical trials; 6) Those with severe primary cardiovascular lesions, pulmonary diseases, endocrine and metabolic diseases or serious diseases affecting their survival, such as tumors or AIDS, which in the opinion of the investigator are not suitable for enrollment; 7) Those with severe hepatic lesions, renal lesions, and hematologic lesions, such as renal function exceeding the upper limit of normal values and hepatic function exceeding two times the upper limit of normal values; and 8) Those with viral hepatitis, infectious diseases, severe abnormalities of coagulation mechanism and other diseases that the investigator considers inappropriate for surgery; 9) Pregnant or lactating women, or those who plan to conceive during the follow-up period, with a positive result of urinary human chorionic gonadotropin test prior to sampling; menstruating women should wait until the end of their menstruation period to undergo the surgery; 10) Patients with severe neurological or psychiatric disorders; 11) Those with a suspected or confirmed alcoholic substance abuse history; 12) Vulnerable groups: mentally ill, critically ill patients, pregnant women, illiterate, minors, cognitively impaired.
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05994872
Start Date
May 31 2024
End Date
December 31 2027
Last Update
August 16 2023
Active Locations (6)
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1
The First People's Hospital of Huzhou
Huzhou, Zhejiang, China, 313000
2
Lishui Municipal Central Hospital
Lishui, Zhejiang, China, 323000
3
Jiande First People's Hospital
Meicheng, Zhejiang, China, 311600
4
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315000