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Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique

Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04906538
Enrollment
38
Registered
2021-05-28
Start date
2018-09-01
Completion date
2021-04-01
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Rolimeter, ACLR, internal suture augmentation, IKDC score, Lysholm score

Brief summary

The purpose of this study is (1) To report, compare and corelate the patient reported outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following hamstring autograft ACLR with and without independent suture tape reinforcement against objective laxity test using Lachmeter. (2) Rate of complications and reoperation.

Detailed description

Investigators performed a randomized control trial in two groups utilizing All- inside ACLR. Group I was augmented by suture tape and Group 2 without suture tape augmentation. From October 2018 to June 2020, 20 patients underwent all-inside ACL reconstruction with internal suture augmentation technique (Group I, Brace group) and the other 18 patients underwent all- inside ACL reconstruction without internal suture augmentation technique (Group II, non-brace group). Demographic data (age, sex, side of injury, time since injury), manual assessment (Lachman test, pivot shift test, ROM), PROs (IKDC score, Lysholm score) and Lachmeter examination were collected and analyzed at fixed time points during follow-up period as mean duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).

Interventions

PROCEDUREall- inside anterior cruciate ligament reconstruction

all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Age 20-35 years old. * Patients will be diagnosed as ACL tear by the following: I. History of knee traumatic event. II. Clinical examination (ant. Drawer test, Lachman test and pivot shift test). III. Radiological evidence of ACL tear by MRI.

Exclusion criteria

* Other intra or extra articular knee injuries. * Previous ACL surgery on the affected knee. * Bilateral ACL injuries. * Significant Articular surface injury. * Medical comorbidities * Patients with malalignment (genu varum. Genu valgum and Genu recurvatum) * Neuromuscular disorders

Design outcomes

Primary

MeasureTime frameDescription
Lachmeter examination9 monthsobjective measurement of knee laxity
Lysholm score9 monthssubjective knee functional score (0 - 100) score. 100 is better in function
International Knee Documentation score (IKDC) score9 monthssubjective knee functional score (0 - 100) score. 100 is better in function

Secondary

MeasureTime frameDescription
knee ROM9 monthspost- operative knee ROM

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026