NCT04906538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

2.6 years

First QC Date

May 25, 2021

Last Update Submit

May 28, 2021

Conditions

Anterior Cruciate Ligament Injuries

Keywords

RolimeterACLRinternal suture augmentationIKDC scoreLysholm score

Outcome Measures

Primary Outcomes (3)

  • Lachmeter examination

    objective measurement of knee laxity

    9 months

  • Lysholm score

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

    9 months

  • International Knee Documentation score (IKDC) score

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

    9 months

Secondary Outcomes (1)

  • knee ROM

    9 months

Study Arms (2)

anterior cruciate ligament reconstruction with internal suture augmentation technique

ACTIVE COMPARATOR

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

Procedure: all- inside anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction without internal suture augmentation technique

ACTIVE COMPARATOR

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

Procedure: all- inside anterior cruciate ligament reconstruction

Interventions

all- inside anterior cruciate ligament reconstructionPROCEDURE

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

anterior cruciate ligament reconstruction with internal suture augmentation techniqueanterior cruciate ligament reconstruction without internal suture augmentation technique

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Cairo, Egypt

Location

Related Publications (1)

  • Sobhy MH, Khater AH, Hassan MR, El Shazly O. Do functional outcomes and cuff integrity correlate after single- versus double-row rotator cuff repair? A systematic review and meta-analysis study. Eur J Orthop Surg Traumatol. 2018 May;28(4):593-605. doi: 10.1007/s00590-018-2145-7. Epub 2018 Feb 13.

    PMID: 29442181BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Ahmed A Khater, MD

    Professor of orthopedic surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
orthopedic surgery registrar

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

September 1, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations

EG(1)