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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of ACL Reconstruction With Stump Preservation and Stump Resection

NCT05364398

Knee Ligament Injury

COMPLETED NA

Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients

NCT05962580

Anterior Cruciate Ligament Tear

COMPLETED NA

Effect of ACL Reconstruction in Biomechanical Properties of Ankle Joint Complex

NCT06631690

Anterior Cruciate Ligament Tear Ankle Sprains

RECRUITING NA

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

NCT07023653

Anterior Cruciate Ligament Rupture

RECRUITING NA

Remnant Preservation and Tibial Tunnel Widening After ACL Reconstruction

NCT07236593

Anterior Cruciate Ligament Injury

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

anterior cruciate ligament reconstruction with internal suture augmentation technique

This group will be operated by using all-inside ACLR technique with internal suture augmentation technique

Group Type ACTIVE_COMPARATOR

all- inside anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

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

anterior cruciate ligament reconstruction without internal suture augmentation technique

This group will be operated by using all-inside ACLR technique without internal suture augmentation technique

Group Type ACTIVE_COMPARATOR

all- inside anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

all- inside anterior cruciate ligament reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No