Anterior Cruciate Ligament RuptureNCT07023653
Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures
A study testing All-Inside Techniques and Complete Tibial Tunnel techniques in people with Anterior Cruciate Ligament Rupture, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
This study aims to compare the functional outcomes of patients with ACL rupture following ACL reconstruction surgery using hamstring grafts, between the all-inside technique and the complete tibial tunnel technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- All-Inside Techniques and Complete Tibial Tunnel techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIndonesia
- Study dates
- 15 Oct 2024to 1 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with anterior cruciate ligament rupture
- Patients within the age range of 18 to 65 years
Who cannot join
- Patients with Multiple Ligament Injuries in the Knee Joint
- Patients with a pregnancy condition
- Patients with Severe Osteochondral Defect (ICRS 4)
- Patients with signs of inflamation in knee joint
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites, 2 recruiting
- Recruiting
Indonesian University Hospital
Depok
dr. Adisa Yusuf Reksoprodjo SpOT (K)
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat
Prof. Dr. Andri M.T. Lubis, MD, +628161177078, andri_lubis@yahoo.com
Prof. Dr. Andri M.T. Lubis, MD
About this study
This study aims to compare the functional outcomes of patients with ACL rupture following ACL reconstruction surgery using hamstring grafts, between the all-inside technique and the complete tibial tunnel technique. The hamstring graft, which serves as the tissue substitute for the damaged ACL, is harvested from the posterior thigh of the patient and used to replace the torn ligament during reconstruction
Read the detailed description
This Study was conducted usingdouble blind randomized controlled trial (RCT), patients who agree to participate in the study will be randomized to undergo ACL reconstruction using either the All-inside technique or the complete tibial tunnel technique. Clinical outcomes, including tibial translation, pain severity, IKDC score, and Tegner score, will be evaluated through anamnesis and physical examination at the outpatient orthopedic clinic at 3, 6, 9, and 12 months postoperatively.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- All-Inside Techniques, Complete Tibial Tunnel techniques
- Keywords
- All-inside Techniques
- 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.
All-Inside TechniquesProcedure or surgery
All-inside ACL reconstruction technique avoids creating full-length bone tunnels. Instead, it uses retrograde drilling to form bone sockets, and the graft is secured with adjustable-loop suspensory fixation on both the femur and tibia.
Complete Tibial Tunnel techniquesProcedure or surgery
Complete Tibial Tunnel Technique is a conventional technique for ACL reconstruction which involves the creation of full-length bone tunnels in the tibia for graft passage via an anterograde approach. Graft fixation is typically achieved using a bio-interference screw on the tibial side and a fixed-loop suspensory device on the femoral side
| Study group | Role | What they receive |
|---|---|---|
| All-Inside Technique | Active comparator | Patients With ACL Ruptures will undergo ACL reconstruction surgery with All-inside techniques Receives: Procedure: All-Inside Techniques |
| Complete Tibial Tunnel | Active comparator | Patients With ACL Ruptures will undergo ACL reconstruction surgery with complete tibial tunnel techniques Receives: Procedure: Complete Tibial Tunnel techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial Translation
Objective measurement of the anterior tibial translation relative to the femur will be performed using a rolimeter during the Lachman test.
Measured: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Pain scale using Visual Analogue Scales
Pain scale on the injured knee, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.
Measured: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
International Knee Documentation Comittee (IKDC) Score
Knee Function Assessment
Measured: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Tegner-Lysholm Score Knee Scoring Scale
a tool to assess knee function
Measured: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Hamstring Graft Diameter
The thickness of the hamstring graft after harvesting and folding will be measured using a sizing block with various intra-operative hole sizes
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start15 Oct 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andri Maruli Tua Lubis, Universitas Indonesia
- Investigators
- Prof. Dr. dr. Andri M.T. Lubis SpOT (K), Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023653
- Sponsor's protocol ID
- 24-07-0995
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kouloumentas P, Kavroudakis E, Charalampidis E, Kavroudakis D, Triantafyllopoulos GK. Superior knee flexor strength at 2 years with all-inside short-graft anterior cruciate ligament reconstruction vs a conventional hamstring technique. Knee Surg Sports Traumatol Arthrosc. 2019 Nov;27(11):3592-3598. doi: 10.1007/s00167-019-05456-9. Epub 2019 Mar 19.
PubMed 30888448Rahardja R, Zhu M, Love H, Clatworthy MG, Monk AP, Young SW. Effect of Graft Choice on Revision and Contralateral Anterior Cruciate Ligament Reconstruction: Results From the New Zealand ACL Registry. Am J Sports Med. 2020 Jan;48(1):63-69. doi: 10.1177/0363546519885148. Epub 2019 Nov 15.
PubMed 31730379Samitier G, Vinagre G. Hamstring Braid Graft Technique for Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2019 Jul 19;8(8):e815-e820. doi: 10.1016/j.eats.2019.03.022. eCollection 2019 Aug.
PubMed 31696044Kennedy JC, Weinberg HW, Wilson AS. The anatomy and function of the anterior cruciate ligament. As determined by clinical and morphological studies. J Bone Joint Surg Am. 1974 Mar;56(2):223-35. No abstract available.
PubMed 4452683Girgis FG, Marshall JL, Monajem A. The cruciate ligaments of the knee joint. Anatomical, functional and experimental analysis. Clin Orthop Relat Res. 1975 Jan-Feb;(106):216-31. doi: 10.1097/00003086-197501000-00033.
PubMed 1126079Tan JL, Chang PC, Mitra AK, Tay BK. Anthropometry of anterior cruciate ligament in Singaporean Chinese. Ann Acad Med Singap. 1998 Nov;27(6):776-9.
PubMed 10101548Pontoh LA, Rahyussalim AJ, Widodo W, Fiolin J, Rhatomy S. Anthropometric study as a predictor of anterior cruciate ligament sizes in Asian Indonesian population. J Orthop Surg (Hong Kong). 2021 Jan-Apr;29(1):23094990211000462. doi: 10.1177/23094990211000462.
PubMed 33745362Brown JA, Brophy RH, Franco J, Marquand A, Solomon TC, Watanabe D, Mandelbaum BR. Avoiding allograft length mismatch during anterior cruciate ligament reconstruction: patient height as an indicator of appropriate graft length. Am J Sports Med. 2007 Jun;35(6):986-9. doi: 10.1177/0363546506298584. Epub 2007 Mar 2.
PubMed 17337725Denti M, Bigoni M, Randelli P, Monteleone M, Cevenini A, Ghezzi A, Schiavone Panni A, Trevisan C. Graft-tunnel mismatch in endoscopic anterior cruciate ligament reconstruction. Intraoperative and cadaver measurement of the intra-articular graft length and the length of the patellar tendon. Knee Surg Sports Traumatol Arthrosc. 1998;6(3):165-8. doi: 10.1007/s001670050093.
PubMed 9704323Meijer K, Saper M, Joyner P, Liu W, Andrews JR, Roth C. Minimizing Graft-Tunnel Mismatch in Allograft Anterior Cruciate Ligament Reconstruction Using Blumensaat's Line: A Cadaveric Study. Arthroscopy. 2018 Aug;34(8):2438-2443.e1. doi: 10.1016/j.arthro.2018.03.006. Epub 2018 May 3.
PubMed 29730211Chiang ER, Ma HL, Wang ST, Hung SC, Liu CL, Chen TH. Hamstring graft sizes differ between Chinese and Caucasians. Knee Surg Sports Traumatol Arthrosc. 2012 May;20(5):916-21. doi: 10.1007/s00167-011-1653-3. Epub 2011 Aug 25.
PubMed 21866349Tang SP, Wan KH, Lee RH, Wong KK, Wong KK. Influence of hamstring autograft diameter on graft failure rate in Chinese population after anterior cruciate ligament reconstruction. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2020 Aug 12;22:45-48. doi: 10.1016/j.asmart.2020.07.005. eCollection 2020 Oct.
PubMed 32913712Colombet P, Graveleau N. An Anterior Cruciate Ligament Reconstruction Technique With 4-Strand Semitendinosus Grafts, Using Outside-In Tibial Tunnel Drilling and Suspensory Fixation Devices. Arthrosc Tech. 2015 Sep 28;4(5):e507-11. doi: 10.1016/j.eats.2015.05.014. eCollection 2015 Oct.
PubMed 26697313Takahashi T, Watanabe S, Ito T. A Surgical Technique for Anterior Cruciate Ligament Reconstruction Using Semitendinosus Graft: An All-Inside Transfemoral Approach. Arthrosc Tech. 2023 May 29;12(6):e975-e982. doi: 10.1016/j.eats.2023.02.035. eCollection 2023 Jun.
PubMed 37424637Jones PE, Schuett DJ. All-Inside Anterior Cruciate Ligament Reconstruction as a Salvage for Small or Attenuated Hamstring Grafts. Arthrosc Tech. 2018 Apr 9;7(5):e453-e457. doi: 10.1016/j.eats.2017.11.007. eCollection 2018 May.
PubMed 29868418
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures
- ClinicalTrials.gov ID
- NCT07023653
- Acronym / sponsor ID
- 24-07-0995
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- All-inside Techniques
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jun 2025 (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.
This study aims to compare the functional outcomes of patients with ACL rupture following ACL reconstruction surgery using hamstring grafts, between the all-inside technique and the complete tibial tunnel technique. The hamstring graft, which serves as the tissue substitute for the damaged ACL, is harvested from the posterior thigh of the patient and used to replace the torn ligament during reconstruction
Detailed description
This Study was conducted usingdouble blind randomized controlled trial (RCT), patients who agree to participate in the study will be randomized to undergo ACL reconstruction using either the All-inside technique or the complete tibial tunnel technique. Clinical outcomes, including tibial translation, pain severity, IKDC score, and Tegner score, will be evaluated through anamnesis and physical examination at the outpatient orthopedic clinic at 3, 6, 9, and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All-Inside Technique | Active comparator | Procedure: All-Inside TechniquesPatients With ACL Ruptures will undergo ACL reconstruction surgery with All-inside techniques |
| Complete Tibial Tunnel | Active comparator | Procedure: Complete Tibial Tunnel techniquesPatients With ACL Ruptures will undergo ACL reconstruction surgery with complete tibial tunnel techniques |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with anterior cruciate ligament rupture
- Patients within the age range of 18 to 65 years
Key exclusion criteria (4 listed)
- Patients with Multiple Ligament Injuries in the Knee Joint
- Patients with a pregnancy condition
- Patients with Severe Osteochondral Defect (ICRS 4)
- Patients with signs of inflamation in knee joint
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 |
|---|---|---|
| All-Inside TechniquesAll-inside ACL reconstruction technique avoids creating full-length bone tunnels. Instead, it uses retrograde drilling to form bone sockets, and the graft is secured with adjustable-loop suspensory fixation on both the femur and tibia. | Procedure or surgery | All-Inside Technique |
| Complete Tibial Tunnel techniquesComplete Tibial Tunnel Technique is a conventional technique for ACL reconstruction which involves the creation of full-length bone tunnels in the tibia for graft passage via an anterograde approach. Graft fixation is typically achieved using a bio-interference screw on the tibial side and a fixed-loop suspensory device on the femoral side | Procedure or surgery | Complete Tibial Tunnel |
Primary outcome
Tibial Translation
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Objective measurement of the anterior tibial translation relative to the femur will be performed using a rolimeter during the Lachman test.
Pain scale using Visual Analogue Scales
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Pain scale on the injured knee, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.
International Knee Documentation Comittee (IKDC) Score
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Knee Function Assessment
Tegner-Lysholm Score Knee Scoring Scale
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
a tool to assess knee function
Hamstring Graft Diameter
Time frame: Intra-operative
The thickness of the hamstring graft after harvesting and folding will be measured using a sizing block with various intra-operative hole sizes
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 17 Jun 2025.
- Background: PubMed 30888448Kouloumentas P, Kavroudakis E, Charalampidis E, Kavroudakis D, Triantafyllopoulos GK. Superior knee flexor strength at 2 years with all-inside short-graft anterior cruciate ligament reconstruction vs a conventional hamstring technique. Knee Surg Sports Traumatol Arthrosc. 2019 Nov;27(11):3592-3598. doi: 10.1007/s00167-019-05456-9. Epub 2019 Mar 19.
- Background: PubMed 31730379Rahardja R, Zhu M, Love H, Clatworthy MG, Monk AP, Young SW. Effect of Graft Choice on Revision and Contralateral Anterior Cruciate Ligament Reconstruction: Results From the New Zealand ACL Registry. Am J Sports Med. 2020 Jan;48(1):63-69. doi: 10.1177/0363546519885148. Epub 2019 Nov 15.
- Background: PubMed 31696044Samitier G, Vinagre G. Hamstring Braid Graft Technique for Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2019 Jul 19;8(8):e815-e820. doi: 10.1016/j.eats.2019.03.022. eCollection 2019 Aug.
- Background: PubMed 4452683Kennedy JC, Weinberg HW, Wilson AS. The anatomy and function of the anterior cruciate ligament. As determined by clinical and morphological studies. J Bone Joint Surg Am. 1974 Mar;56(2):223-35. No abstract available.
- Background: PubMed 1126079Girgis FG, Marshall JL, Monajem A. The cruciate ligaments of the knee joint. Anatomical, functional and experimental analysis. Clin Orthop Relat Res. 1975 Jan-Feb;(106):216-31. doi: 10.1097/00003086-197501000-00033.
- Background: PubMed 10101548Tan JL, Chang PC, Mitra AK, Tay BK. Anthropometry of anterior cruciate ligament in Singaporean Chinese. Ann Acad Med Singap. 1998 Nov;27(6):776-9.
- Background: PubMed 33745362Pontoh LA, Rahyussalim AJ, Widodo W, Fiolin J, Rhatomy S. Anthropometric study as a predictor of anterior cruciate ligament sizes in Asian Indonesian population. J Orthop Surg (Hong Kong). 2021 Jan-Apr;29(1):23094990211000462. doi: 10.1177/23094990211000462.
- Background: PubMed 17337725Brown JA, Brophy RH, Franco J, Marquand A, Solomon TC, Watanabe D, Mandelbaum BR. Avoiding allograft length mismatch during anterior cruciate ligament reconstruction: patient height as an indicator of appropriate graft length. Am J Sports Med. 2007 Jun;35(6):986-9. doi: 10.1177/0363546506298584. Epub 2007 Mar 2.
- Background: PubMed 9704323Denti M, Bigoni M, Randelli P, Monteleone M, Cevenini A, Ghezzi A, Schiavone Panni A, Trevisan C. Graft-tunnel mismatch in endoscopic anterior cruciate ligament reconstruction. Intraoperative and cadaver measurement of the intra-articular graft length and the length of the patellar tendon. Knee Surg Sports Traumatol Arthrosc. 1998;6(3):165-8. doi: 10.1007/s001670050093.
- Background: PubMed 29730211Meijer K, Saper M, Joyner P, Liu W, Andrews JR, Roth C. Minimizing Graft-Tunnel Mismatch in Allograft Anterior Cruciate Ligament Reconstruction Using Blumensaat's Line: A Cadaveric Study. Arthroscopy. 2018 Aug;34(8):2438-2443.e1. doi: 10.1016/j.arthro.2018.03.006. Epub 2018 May 3.
- Background: PubMed 21866349Chiang ER, Ma HL, Wang ST, Hung SC, Liu CL, Chen TH. Hamstring graft sizes differ between Chinese and Caucasians. Knee Surg Sports Traumatol Arthrosc. 2012 May;20(5):916-21. doi: 10.1007/s00167-011-1653-3. Epub 2011 Aug 25.
- Background: PubMed 32913712Tang SP, Wan KH, Lee RH, Wong KK, Wong KK. Influence of hamstring autograft diameter on graft failure rate in Chinese population after anterior cruciate ligament reconstruction. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2020 Aug 12;22:45-48. doi: 10.1016/j.asmart.2020.07.005. eCollection 2020 Oct.
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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.
Prof. Dr. dr. Andri M.T. Lubis SpOT (K) principal investigator
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All-Inside Techniques and Complete Tibial Tunnel techniques in people with Anterior Cruciate Ligament Rupture, run by Universitas Indonesia at 2 sites in Indonesia.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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. 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 Prof. Dr. dr. Andri M.T. Lubis SpOT (K) (+628161177078, andri_lubis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibial Translation (time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery). The study lists 5 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 NCT07023653, which also lists 32 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 17 Jun 2025.