Anterior Cruciate Ligament InjuryNCT07236593
Remnant Preservation and Tibial Tunnel Widening After ACL Reconstruction
A study testing Stump-Suturing ACL Reconstruction and Stump-Resection ACL Reconstruction in people with Anterior Cruciate Ligament Injury, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Stump-Suturing ACL Reconstruction and Stump-Resection ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years
- Acute ACL injury (<6 months)
- Medically fit for surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remnant Preservation in Anterior Cruciate Ligament Reconstruction: Does Stump Suturing Reduce the Risk of Tibial Tunnel Widening? A CT-Based Study
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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Stump-Suturing ACL Reconstruction, Stump-Resection ACL Reconstruction
- 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.
Stump-Suturing ACL ReconstructionProcedure or surgery
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-Resection ACL ReconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Stump-Suturing ACL Reconstruction | Experimental | Not described Receives: Procedure: Stump-Suturing ACL Reconstruction |
| Stump-Resection ACL Reconstruction | Active comparator | Not described Receives: Procedure: Stump-Resection ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Tibial Tunnel Enlargement
Measured: 12 months postoperatively
Secondary outcomes (4)
Percentage of Tibial Tunnel Enlargement
Measured: 12 months
Tibial Tunnel Positioning (X & Y coordinates)
Measured: 2 Weeks
Femoral Tunnel Diameter Change
Measured: 12 months
Femoral Tunnel Positioning (X & Y coordinates)
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jul 2021
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed El-Desouky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236593
- Sponsor's protocol ID
- N-473-2021
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Desouky M, Elkalyoby AS, Rashwan AS, Gaballah AI, Abdelrazek BH. Remnant preservation and stump suturing in anterior cruciate ligament reconstruction reduce tibial tunnel widening without compromising tunnel placement: A computed tomography-based randomised controlled trial. J Exp Orthop. 2026 Oct 28;13(4):e70962. doi: 10.1002/jeo2.70962. eCollection 2026 Oct.
PubMed 42953369
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remnant Preservation in Anterior Cruciate Ligament Reconstruction: Does Stump Suturing Reduce the Risk of Tibial Tunnel Widening? A CT-Based Study
- ClinicalTrials.gov ID
- NCT07236593
- Acronym / sponsor ID
- N-473-2021
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 19 Nov 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stump-Suturing ACL Reconstruction | Experimental | Procedure: Stump-Suturing ACL Reconstruction |
| Stump-Resection ACL Reconstruction | Active comparator | Procedure: Stump-Resection ACL Reconstruction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 45 years
- Acute ACL injury (<6 months)
- Medically fit for surgery
Key exclusion criteria (6 listed)
- Age <18 or >45 years
- Old or chronic ACL injuries (>6 months)
- Multi-ligamentous knee injuries
- Failed previous ACL reconstruction
- Associated mal-alignment deformities
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 |
|---|---|---|
| Stump-Suturing ACL ReconstructionPatients 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. | Procedure or surgery | Stump-Suturing ACL Reconstruction |
| Stump-Resection ACL ReconstructionPatients 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. | Procedure or surgery | Stump-Resection ACL Reconstruction |
Primary outcome
Rate of Tibial Tunnel Enlargement
Time frame: 12 months postoperatively
4 secondary outcomes
Percentage of Tibial Tunnel Enlargement
Time frame: 12 months
Tibial Tunnel Positioning (X & Y coordinates)
Time frame: 2 Weeks
Femoral Tunnel Diameter Change
Time frame: 12 months
Femoral Tunnel Positioning (X & Y coordinates)
Time frame: 2 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 42953369El-Desouky M, Elkalyoby AS, Rashwan AS, Gaballah AI, Abdelrazek BH. Remnant preservation and stump suturing in anterior cruciate ligament reconstruction reduce tibial tunnel widening without compromising tunnel placement: A computed tomography-based randomised controlled trial. J Exp Orthop. 2026 Oct 28;13(4):e70962. doi: 10.1002/jeo2.70962. eCollection 2026 Oct.
Related trials for Anterior Cruciate Ligament Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stump-Suturing ACL Reconstruction and Stump-Resection ACL Reconstruction in people with Anterior Cruciate Ligament Injury, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Tibial Tunnel Enlargement (time frame: 12 months postoperatively). 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 NCT07236593, which also lists 1 linked publication.
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 19 Nov 2025.