- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236593
Remnant Preservation and Tibial Tunnel Widening After ACL Reconstruction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Kasr Alainy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 45 years
- Acute ACL injury (<6 months)
- Medically fit for surgery
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stump-Suturing ACL Reconstruction
|
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.
|
|
Active Comparator: Stump-Resection 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of Tibial Tunnel Enlargement
Time Frame: 12 months postoperatively
|
12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Tibial Tunnel Enlargement
Time Frame: 12 months
|
12 months
|
|
Tibial Tunnel Positioning (X & Y coordinates)
Time Frame: 2 Weeks
|
2 Weeks
|
|
Femoral Tunnel Diameter Change
Time Frame: 12 months
|
12 months
|
|
Femoral Tunnel Positioning (X & Y coordinates)
Time Frame: 2 Weeks
|
2 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-473-2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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