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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Reverse drilling technique
Traditional extraction drilling
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Reverse drilling technique, Anterior cruciate ligament reconstruction, Tendon-to-bone healing

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Traditional extraction drilling

Reverse drilling technique

Arm Description

A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel (n = 108).

A standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel (n = 108).

Outcomes

Primary Outcome Measures

IKDC Subjective Score
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.
Bone tunnel enlargement
Measurement of bone tunnel enlargement through postoperative image

Secondary Outcome Measures

Instrumented AP Knee Laxity
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.

Full Information

First Posted
August 9, 2023
Last Updated
August 9, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Ningbo Medical Center Lihuili Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Shaoxing Traditional Chinese Medicine Hospital, Lishui Municipal Central Hospital, The First People's Hospital of Huzhou, Jiande First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05994872
Brief Title
Reverse Drilling Technique in Improving Outcomes After Arthroscopic Anterior Cruciate Ligament Reconstruction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2024 (Anticipated)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Ningbo Medical Center Lihuili Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Shaoxing Traditional Chinese Medicine Hospital, Lishui Municipal Central Hospital, The First People's Hospital of Huzhou, Jiande First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
Reverse drilling technique, Anterior cruciate ligament reconstruction, Tendon-to-bone healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Surgical doctor team, patient, outcome assessor, data analyst and image reviewer are masked.
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional extraction drilling
Arm Type
Sham Comparator
Arm Description
A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel (n = 108).
Arm Title
Reverse drilling technique
Arm Type
Experimental
Arm Description
A standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel (n = 108).
Intervention Type
Procedure
Intervention Name(s)
Reverse drilling technique
Intervention Description
A standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel.
Intervention Type
Procedure
Intervention Name(s)
Traditional extraction drilling
Intervention Description
A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel.
Primary Outcome Measure Information:
Title
IKDC Subjective Score
Description
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.
Time Frame
Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Title
Bone tunnel enlargement
Description
Measurement of bone tunnel enlargement through postoperative image
Time Frame
Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Secondary Outcome Measure Information:
Title
Instrumented AP Knee Laxity
Description
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.
Time Frame
Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haobo Wu, MD
Phone
+86 13958122387
Email
2505014@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
An Liu, MD
Email
la@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haobo Wu, MD
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
The First People's Hospital of Huzhou
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanfeng Zhang, MD
Facility Name
Jiande First People's Hospital
City
Jiande
State/Province
Zhejiang
ZIP/Postal Code
311600
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Xiao, MD
Facility Name
Lishui Municipal Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Wu, MD
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD
Facility Name
Shaoxing Traditional Chinese Medicine Hospital
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzeng Shen, MD
Facility Name
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
318000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobo Zhou, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35486517
Citation
Hoogeslag RAG, Huis In 't Veld R, Brouwer RW, de Graaff F, Verdonschot N. Acute Anterior Cruciate Ligament Rupture: Repair or Reconstruction? Five-Year Results of a Randomized Controlled Clinical Trial. Am J Sports Med. 2022 Jun;50(7):1779-1787. doi: 10.1177/03635465221090527. Epub 2022 Apr 29.
Results Reference
result
PubMed Identifier
32298131
Citation
Murray MM, Fleming BC, Badger GJ; BEAR Trial Team; Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. Am J Sports Med. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Epub 2020 Apr 16.
Results Reference
result
PubMed Identifier
35988569
Citation
Beard DJ, Davies L, Cook JA, Stokes J, Leal J, Fletcher H, Abram S, Chegwin K, Greshon A, Jackson W, Bottomley N, Dodd M, Bourke H, Shirkey BA, Paez A, Lamb SE, Barker K, Phillips M, Brown M, Lythe V, Mirza B, Carr A, Monk P, Morgado Areia C, O'Leary S, Haddad F, Wilson C, Price A; ACL SNNAP Study Group. Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial. Lancet. 2022 Aug 20;400(10352):605-615. doi: 10.1016/S0140-6736(22)01424-6.
Results Reference
result
PubMed Identifier
16325084
Citation
Fauno P, Kaalund S. Tunnel widening after hamstring anterior cruciate ligament reconstruction is influenced by the type of graft fixation used: a prospective randomized study. Arthroscopy. 2005 Nov;21(11):1337-41. doi: 10.1016/j.arthro.2005.08.023.
Results Reference
result
PubMed Identifier
25681503
Citation
Weber AE, Delos D, Oltean HN, Vadasdi K, Cavanaugh J, Potter HG, Rodeo SA. Tibial and Femoral Tunnel Changes After ACL Reconstruction: A Prospective 2-Year Longitudinal MRI Study. Am J Sports Med. 2015 May;43(5):1147-56. doi: 10.1177/0363546515570461. Epub 2015 Feb 13.
Results Reference
result
PubMed Identifier
36326437
Citation
Yang W, Li C, Ji X, Yao M, Hong J, Qu Z, Liu A, Wu H. Synergistic Effect of Reverse Drilling and Bone Dust on Femoral Tendon-Bone Healing After Anterior Cruciate Ligament Reconstruction in a Rabbit Model. Am J Sports Med. 2022 Dec;50(14):3844-3855. doi: 10.1177/03635465221129267. Epub 2022 Nov 3.
Results Reference
result

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

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