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

May 28, 2021 updated by: Ahmed abdelaziz Ramadan, Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: 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
Procedure: all- inside anterior cruciate ligament reconstruction
all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique
Active Comparator: 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
Procedure: all- inside anterior cruciate ligament reconstruction
all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lachmeter examination
Time Frame: 9 months
objective measurement of knee laxity
9 months
Lysholm score
Time Frame: 9 months
subjective knee functional score (0 - 100) score. 100 is better in function
9 months
International Knee Documentation score (IKDC) score
Time Frame: 9 months
subjective knee functional score (0 - 100) score. 100 is better in function
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knee ROM
Time Frame: 9 months
post- operative knee ROM
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed A Khater, MD, Professor of orthopedic surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 310 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

study protocol and abstract

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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