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

August 9, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Randomized Controlled Trial of Reverse Drilling Technique in Improving Outcomes After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Prospective, Multicenter, Single-blind, Randomized Controlled Surgical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 conventional extraction reaming by which an enlarged gap is created and initial direct integration is limited between implants and bone, as chunks of cancellous bone are torn out, thereby being removed outside the tunnel. Biologically, a compaction technique was reported to increase the bone volume around grafts and provide a larger area of bone-to-graft contact for bone integration because of the spring-back effect. Mechanically, compaction of the bone graft into the femoral tunnel was reported to significantly increase stiffness of the grafts. Reverse drilling (RD) can compress peritunnel bone at the time of bone tunnel preparation to make the tunnel wall denser and smoother in comparison with extraction drilling (ED), reverse drilling yields the same compaction effect as the compaction technique. Bone dust (BD) is commonly defined as pieces of bone produced by a power-driven tool. It is universally accepted that bone debris more than 200 mm in particle size is classified as particulate bone and that bone debris no more than 200 mm is classified as BD. When applied for ACLR, BD could fully utilize the advantages of an autologous bone graft while avoiding invasive and traumatic bone harvesting procedures, as bone tunnel preparation is accompanied by the production of a considerable amount of BD. Therefore, BD grafting is promising for improving tendon-bone healing with safety and simplification. We refer to the technique of retaining BD in the bone tunnel after RD as the reverse drilling technique. We hyposize that reverse drilling technique can improve outcomes after arthroscopic anterior cruciate ligament reconstruction by improving peritunnel bone and preventing bone tunnel enlargement.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Huzhou, Zhejiang, China, 313000
        • The First People's Hospital of Huzhou
        • Contact:
          • Zhanfeng Zhang, MD
      • Jiande, Zhejiang, China, 311600
        • Jiande First People's Hospital
        • Contact:
          • Jie Xiao, MD
      • Lishui, Zhejiang, China, 323000
        • Lishui Municipal Central Hospital
        • Contact:
          • Weidong Wu, MD
      • Ningbo, Zhejiang, China, 315000
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
          • Jin Li, MD
      • Shaoxing, Zhejiang, China, 312000
        • Shaoxing Traditional Chinese Medicine Hospital
        • Contact:
          • Jianzeng Shen, MD
      • Taizhou, Zhejiang, China, 318000
        • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
        • Contact:
          • Xiaobo Zhou, MD

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

  • Adult

Accepts Healthy Volunteers

No

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Traditional extraction drilling
A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel (n = 108).
Procedure: Traditional extraction drilling
A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel.
Experimental: Reverse drilling technique
A standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel (n = 108).
Procedure: Reverse drilling technique
A standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC Subjective Score
Time Frame: Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
This table consists of knee joint assessment (10 items) and knee ligament examination (8 items), which includes joint pain, exercise level, and daily activity ability, with a total score of 0-100 points.
Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Bone tunnel enlargement
Time Frame: Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Measurement of bone tunnel enlargement through postoperative image
Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumented AP Knee Laxity
Time Frame: Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Arthrometer testing (KT-1000; MEDMetric) was used to measure the anterior displacement of the tibia with respect to the femur under 130 N of applied anterior force and performed in duplicate on each leg.
Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

Investigators

  • Study Chair: Haobo Wu, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

May 31, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0562

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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