NCT05994872

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
May 2024Dec 2027

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 9, 2023

Last Update Submit

August 9, 2023

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Reverse drilling techniqueAnterior cruciate ligament reconstructionTendon-to-bone healing

Outcome Measures

Primary Outcomes (2)

  • 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.

    Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.

  • Bone tunnel enlargement

    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 Outcomes (1)

  • Instrumented AP Knee Laxity

    Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.

Study Arms (2)

Traditional extraction drilling

SHAM COMPARATOR

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

Procedure: Traditional extraction drilling

Reverse drilling technique

EXPERIMENTAL

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

Procedure: Reverse drilling technique

Interventions

Reverse drilling techniquePROCEDURE

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

Reverse drilling technique
Traditional extraction drillingPROCEDURE

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

Traditional extraction drilling

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The First People's Hospital of Huzhou

Huzhou, Zhejiang, 313000, China

Location

Lishui Municipal Central Hospital

Lishui, Zhejiang, 323000, China

Location

Jiande First People's Hospital

Meicheng, Zhejiang, 311600, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Location

Shaoxing Traditional Chinese Medicine Hospital

Shaoxing, Zhejiang, 312000, China

Location

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Taizhou, Zhejiang, 318000, China

Location

Related Publications (6)

  • 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.

    PMID: 35486517RESULT

  • 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.

    PMID: 32298131RESULT

  • 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.

    PMID: 35988569RESULT

  • 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.

    PMID: 16325084RESULT

  • 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.

    PMID: 25681503RESULT

  • 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.

    PMID: 36326437RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Haobo Wu, MD

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    STUDY CHAIR

Central Study Contacts

Haobo Wu, MD

CONTACT

+86 139581223872505014@zju.edu.cn

An Liu, MD

CONTACT

la@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Surgical doctor team, patient, outcome assessor, data analyst and image reviewer are masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

May 31, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)