NCT07236593

Brief Summary

Anterior Cruciate Ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures. Tibial tunnel widening is a recognized postoperative complication that may affect graft stability and long-term outcomes. Recent studies have suggested that preserving the ACL remnant may improve biological healing and reduce tunnel widening, but the evidence remains inconclusive. This prospective randomized study aims to evaluate whether remnant (stump) preservation and suturing during ACL reconstruction can reduce the risk of tibial tunnel widening compared with the conventional stump-resection technique. A total of 190 patients with recent ACL tears (\<6 months) were randomly assigned into two equal groups: Group A underwent arthroscopic ACL reconstruction with remnant suturing, while Group B underwent standard reconstruction with stump resection. All patients were followed for 12 months postoperatively with serial CT evaluations to assess tunnel diameters and positioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.7 years

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of Tibial Tunnel Enlargement

    12 months postoperatively

Secondary Outcomes (4)

  • Percentage of Tibial Tunnel Enlargement

    12 months

  • Tibial Tunnel Positioning (X & Y coordinates)

    2 Weeks

  • Femoral Tunnel Diameter Change

    12 months

  • Femoral Tunnel Positioning (X & Y coordinates)

    2 Weeks

Study Arms (2)

Stump-Suturing ACL Reconstruction

EXPERIMENTAL
Procedure: Stump-Suturing ACL Reconstruction

Stump-Resection ACL Reconstruction

ACTIVE COMPARATOR
Procedure: Stump-Resection ACL Reconstruction

Interventions

Patients in this group undergo arthroscopic ACL reconstruction with preservation and suturing of the native ACL remnant (stump) around the graft. The technique aims to enhance graft revascularization and biological healing, potentially reducing tibial tunnel widening.

Stump-Suturing ACL Reconstruction

Patients in this group undergo standard arthroscopic ACL reconstruction with complete resection of the ACL remnant (stump) prior to graft placement. This represents the conventional surgical approach for ACL reconstruction.

Stump-Resection ACL Reconstruction

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45 years
  • Acute ACL injury (\<6 months)
  • Medically fit for surgery

You may not qualify if:

  • Age \<18 or \>45 years
  • Old or chronic ACL injuries (\>6 months)
  • Multi-ligamentous knee injuries
  • Failed previous ACL reconstruction
  • Associated mal-alignment deformities
  • Absence of identifiable ACL stump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy

Cairo, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopedic surgery

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 19, 2025

Study Start

July 1, 2021

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations