Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures

NCT ID: NCT07023653

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-12-01

Brief Summary

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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

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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

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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All-Inside Technique

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

Group Type ACTIVE_COMPARATOR

All-Inside Techniques

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Complete Tibial Tunnel techniques

Intervention Type PROCEDURE

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

Interventions

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All-Inside Techniques

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.

Intervention Type PROCEDURE

Complete Tibial Tunnel techniques

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Andri Maruli Tua Lubis

Prof. Dr. Andri M.T. Lubis, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Indonesian University Hospital

Depok, , Indonesia

Site Status RECRUITING

Cipto Mangunkusumo Hospital

Jakarta Pusat, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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

Role: CONTACT

+628161177078

Facility Contacts

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dr. Adisa Yusuf Reksoprodjo SpOT (K)

Role: primary

Prof. Dr. Andri M.T. Lubis, MD

Role: primary

+628161177078

References

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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.

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Other Identifiers

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24-07-0995

Identifier Type: -

Identifier Source: org_study_id

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