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Clinical Trials in China / NCT05994872
Starting soon Not applicable

Reverse Drilling Technique in Improving Outcomes After Arthroscopic Anterior Cruciate Ligament Reconstruction

NCT05994872 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2024-05-31
Last updated
2023-08-16

Condition(s) studied

Anterior Cruciate Ligament Injuries

Investigational drug(s) / intervention(s)

Reverse drilling techniqueTraditional extraction drilling

Reverse drilling technique: A standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel.

Traditional extraction drilling: A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel.

Study 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 ability and reverse drilling (RD), an easy compaction technique, make it accessible to enhance tendon-bone healing in ACLR. We hyposize that RD and BD synergistically improve outcomes after arthroscopic ACLR by improving peritunnel bone and preventing BTE.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: 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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
The First People's Hospital of Huzhou Huzhou Zhejiang
Lishui Municipal Central Hospital Lishui Zhejiang
Jiande First People's Hospital Meicheng Zhejiang
Ningbo Medical Center Lihuili Hospital Ningbo Zhejiang
Shaoxing Traditional Chinese Medicine Hospital Shaoxing Zhejiang
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University Taizhou Zhejiang

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05994872 on ClinicalTrials.gov ↗ ← All trials in China