NCT07023653

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress75%
Oct 2024Dec 2026

Study Start

First participant enrolled

October 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

June 9, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

All-inside Techniques

Outcome Measures

Primary Outcomes (5)

  • Tibial Translation

    Objective measurement of the anterior tibial translation relative to the femur will be performed using a rolimeter during the Lachman test.

    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.

    Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery

  • International Knee Documentation Comittee (IKDC) Score

    Knee Function Assessment

    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

    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

    Intra-operative

Study Arms (2)

All-Inside Technique

ACTIVE COMPARATOR

Patients With ACL Ruptures will undergo ACL reconstruction surgery with All-inside techniques

Procedure: All-Inside Techniques

Complete Tibial Tunnel

ACTIVE COMPARATOR

Patients With ACL Ruptures will undergo ACL reconstruction surgery with complete tibial tunnel techniques

Procedure: Complete Tibial Tunnel techniques

Interventions

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.

All-Inside Technique

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

Complete Tibial Tunnel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with anterior cruciate ligament rupture
  • Patients within the age range of 18 to 65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indonesian University Hospital

Depok, Indonesia

RECRUITING

Cipto Mangunkusumo Hospital

Jakarta Pusat, Indonesia

RECRUITING

Related Publications (32)

  • 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.

    PMID: 30888448BACKGROUND
  • Rahardja 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.

    PMID: 31730379BACKGROUND
  • Samitier 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.

    PMID: 31696044BACKGROUND
  • Kennedy 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.

    PMID: 4452683BACKGROUND
  • Girgis 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.

    PMID: 1126079BACKGROUND
  • Tan 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.

    PMID: 10101548BACKGROUND
  • Pontoh 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.

    PMID: 33745362BACKGROUND
  • Brown 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.

    PMID: 17337725BACKGROUND
  • Denti 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.

    PMID: 9704323BACKGROUND
  • Meijer 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.

    PMID: 29730211BACKGROUND
  • Chiang 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.

    PMID: 21866349BACKGROUND
  • Tang 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.

    PMID: 32913712BACKGROUND
  • Colombet 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.

    PMID: 26697313BACKGROUND
  • Takahashi 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.

    PMID: 37424637BACKGROUND
  • Jones 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.

    PMID: 29868418BACKGROUND
  • Fritsch B, Figueroa F, Semay B. Graft Preparation Technique to Optimize Hamstring Graft Diameter for Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2017 Nov 13;6(6):e2169-e2175. doi: 10.1016/j.eats.2017.08.011. eCollection 2017 Dec.

    PMID: 29349014BACKGROUND
  • Rante SDT, Santoso A, Sibarani T, Utomo DN. All-inside vs. conventional method in anterior cruciate ligament (ACL) reconstruction: systematic review and meta-analysis. Indones J Biomed Sci. 2022;16(2):47-59.

    BACKGROUND
  • Lubowitz JH, Schwartzberg R, Smith P. Randomized controlled trial comparing all-inside anterior cruciate ligament reconstruction technique with anterior cruciate ligament reconstruction with a full tibial tunnel. Arthroscopy. 2013 Jul;29(7):1195-200. doi: 10.1016/j.arthro.2013.04.009.

    PMID: 23809454BACKGROUND
  • Ashraf Y, Senevirathna SR, Ashraf T. Conventional versus 'all-inside' anterior cruciate ligament reconstruction: a randomized controlled trial comparing hamstring strength and functional outcome. Bone Jt Open. 2020 Nov 4;1(11):706-708. doi: 10.1302/2633-1462.111.BJO-2020-0012.R1.

    PMID: 33241220BACKGROUND
  • Lubowitz JH, Ahmad CS, Anderson K. All-inside anterior cruciate ligament graft-link technique: second-generation, no-incision anterior cruciate ligament reconstruction. Arthroscopy. 2011 May;27(5):717-27. doi: 10.1016/j.arthro.2011.02.008.

    PMID: 21663726BACKGROUND
  • Lubowitz JH. No-tunnel anterior cruciate ligament reconstruction: the transtibial all-inside technique. Arthroscopy. 2006 Aug;22(8):900.e1-11. doi: 10.1016/j.arthro.2006.06.003.

    PMID: 16904591BACKGROUND
  • Morgan CD, Kalmam VR, Grawl DM. Isometry testing for anterior cruciate ligament reconstruction revisited. Arthroscopy. 1995 Dec;11(6):647-59. doi: 10.1016/0749-8063(95)90104-3.

    PMID: 8679023BACKGROUND
  • Lin R, Zhong Q, Wu X, Cui L, Huang R, Deng Q, Zuo J, Jiang C, Li W. Randomized controlled trial of all-inside and standard single-bundle anterior cruciate ligament reconstruction with functional, MRI-based graft maturity and patient-reported outcome measures. BMC Musculoskelet Disord. 2022 Mar 26;23(1):289. doi: 10.1186/s12891-022-05231-x.

    PMID: 35337306BACKGROUND
  • Ardern CL, Taylor NF, Feller JA, Webster KE. Return-to-sport outcomes at 2 to 7 years after anterior cruciate ligament reconstruction surgery. Am J Sports Med. 2012 Jan;40(1):41-8. doi: 10.1177/0363546511422999. Epub 2011 Sep 23.

    PMID: 21946441BACKGROUND
  • Teng Y, Zhang X, Da L, Hu J, Wang H, Han H, Wu M, Zhang S, Xia Y. Whether sutures reduce the graft laceration caused by interference screw in anterior cruciate ligament reconstruction? A biomechanical study in vitro. BMC Musculoskelet Disord. 2021 Jun 22;22(1):571. doi: 10.1186/s12891-021-04457-5.

    PMID: 34158018BACKGROUND
  • Goyal T, Das L, Paul S, Choudhury AK, Sethy SS. Outcomes of retro-drilled all-inside tibial tunnel vs complete tibial tunnel techniques in anterior cruciate ligament reconstruction-a comparative study. Eur J Orthop Surg Traumatol. 2022 Apr;32(3):523-532. doi: 10.1007/s00590-021-03011-2. Epub 2021 May 24.

    PMID: 34028623BACKGROUND
  • Connaughton AJ, Geeslin AG, Uggen CW. All-inside ACL reconstruction: How does it compare to standard ACL reconstruction techniques? J Orthop. 2017 Mar 19;14(2):241-246. doi: 10.1016/j.jor.2017.03.002. eCollection 2017 Jun.

    PMID: 28360487BACKGROUND
  • Bosco F, Giustra F, Ghirri A, Cacciola G, Masse A, Capella M. All-Inside Anterior Cruciate Ligament Reconstruction Technique: Tips and Tricks. J Clin Med. 2023 Sep 6;12(18):5793. doi: 10.3390/jcm12185793.

    PMID: 37762734BACKGROUND
  • Evans S, Shaginaw J, Bartolozzi A. Acl reconstruction - it's all about timing. Int J Sports Phys Ther. 2014 Apr;9(2):268-73.

    PMID: 24790787BACKGROUND
  • Samitier G, Marcano AI, Alentorn-Geli E, Cugat R, Farmer KW, Moser MW. Failure of Anterior Cruciate Ligament Reconstruction. Arch Bone Jt Surg. 2015 Oct;3(4):220-40.

    PMID: 26550585BACKGROUND
  • Deviandri R, van der Veen HC, Lubis AMT, Postma MJ, van den Akker-Scheek I. Translation, Cross-Cultural Adaptation, Validity, and Reliability of the Indonesian Version of the IKDC Subjective Knee Form. Orthop J Sports Med. 2021 Sep 29;9(9):23259671211038372. doi: 10.1177/23259671211038372. eCollection 2021 Sep.

    PMID: 34604432BACKGROUND
  • Deviandri R, van der Veen HC, Lubis AMT, Utoyo GA, van den Akker-Scheek I, Postma MJ. Burden and Cost of Anterior Cruciate Ligament Reconstruction and Reimbursement of Its Treatment in a Developing Country: An Observational Study in Indonesia. Clinicoecon Outcomes Res. 2022 Jul 17;14:479-486. doi: 10.2147/CEOR.S368840. eCollection 2022.

    PMID: 35872972BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Prof. Dr. dr. Andri M.T. Lubis SpOT (K)

    Indonesia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. dr. Andri M.T. Lubis SpOT (K)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Andri M.T. Lubis, MD

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

October 15, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations