Anterior Cruciate Ligament InjuriesNCT05994872
Reverse Drilling Technique in Improving Outcomes After Arthroscopic Anterior Cruciate Ligament Reconstruction
A study testing Reverse drilling technique and Traditional extraction drilling in people with Anterior Cruciate Ligament Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 6 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Reverse drilling technique and Traditional extraction drilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 6 sitesChina
- Study dates
- 31 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
An Liu, MD contact
6 sites in 1 country
China6 sites
The First People's Hospital of Huzhou
Huzhou, Zhejiang, 313000
Zhanfeng Zhang, MD
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323000
Weidong Wu, MD
Jiande First People's Hospital
Meicheng, Zhejiang, 311600
Jie Xiao, MD
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Jin Li, MD
Shaoxing Traditional Chinese Medicine Hospital
Shaoxing, Zhejiang, 312000
Jianzeng Shen, MD
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou, Zhejiang, 318000
Xiaobo Zhou, MD
About this study
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
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Reverse drilling technique, Traditional extraction drilling
- Keywords
- Reverse drilling technique, Anterior cruciate ligament reconstruction, Tendon-to-bone healing
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse drilling techniqueProcedure or surgery
A standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel.
Traditional extraction drillingProcedure or surgery
A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel.
| Study group | Role | What they receive |
|---|---|---|
| Traditional extraction drilling | Sham comparator | A standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel (n = 108). Receives: 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). Receives: Procedure: Reverse drilling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Secondary outcomes (1)
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.
Measured: Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start31 May 2024 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Haobo Wu, MD, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994872
- Sponsor's protocol ID
- 2023-0562
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35486517Murray 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.
PubMed 32298131Beard 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.
PubMed 35988569Fauno 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.
PubMed 16325084Weber 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.
PubMed 25681503Yang 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.
PubMed 36326437
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05994872
- Acronym / sponsor ID
- 2023-0562
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Reverse drilling technique, Anterior cruciate ligament reconstruction, Tendon-to-bone healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- 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
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional extraction drilling | Sham comparator | Procedure: Traditional extraction drillingA standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel (n = 108). |
| Reverse drilling technique | Experimental | Procedure: Reverse drilling techniqueA standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel (n = 108). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse drilling techniqueA standard hamstring autograft procedure was performed using reverse drilling technique to prepare bone tunnel. | Procedure or surgery | Reverse drilling technique |
| Traditional extraction drillingA standard hamstring autograft procedure was performed using traditional extraction drilling to prepare bone tunnel. | Procedure or surgery | Traditional extraction drilling |
Primary outcome
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.
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
1 secondary outcome
Instrumented AP Knee Laxity
Time frame: Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Results publication: PubMed 35486517Hoogeslag 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 publication: PubMed 32298131Murray 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 publication: PubMed 35988569Beard 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 publication: PubMed 16325084Fauno 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 publication: PubMed 25681503Weber 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 publication: PubMed 36326437Yang 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.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
An Liu, MD contact
Haobo Wu, MD study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse drilling technique and Traditional extraction drilling in people with Anterior Cruciate Ligament Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haobo Wu, MD (+86 13958122387, 2505014@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKDC Subjective Score (time frame: Patients will be followed up regularly at 3, 6, 9, 12, and 24 months after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994872, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.