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Completed

NCT Number: NCT04906538

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of medicine

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

all- inside anterior cruciate ligament reconstruction

Procedure

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

Primary outcomes

  1. Lachmeter examination

    Time frame: 9 months

    objective measurement of knee laxity

  2. Lysholm score

    Time frame: 9 months

    subjective knee functional score (0 - 100) score. 100 is better in function

  3. International Knee Documentation score (IKDC) score

    Time frame: 9 months

    subjective knee functional score (0 - 100) score. 100 is better in function

Secondary outcomes

  1. knee ROM

    Time frame: 9 months

    post- operative knee ROM

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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