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

Anterior Cruciate Ligament Injuries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994872
• Other study ID #: 2023-0562
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Haobo Wu, MD
• Phone: +86 13958122387
• Email: 2505014[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• 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.

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	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, The First People's Hospital of Huzhou

Country where clinical trial is conducted

China, 

References & Publications (6)

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, H — View 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. — View 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: 10.1 — View 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 Crucia — View 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. Epu — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.