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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
all- inside anterior cruciate ligament reconstruction
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Rolimeter, ACLR, internal suture augmentation, IKDC score, Lysholm score

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

anterior cruciate ligament reconstruction with internal suture augmentation technique

anterior cruciate ligament reconstruction without internal suture augmentation technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

Lachmeter examination
objective measurement of knee laxity
Lysholm score
subjective knee functional score (0 - 100) score. 100 is better in function
International Knee Documentation score (IKDC) score
subjective knee functional score (0 - 100) score. 100 is better in function

Secondary Outcome Measures

knee ROM
post- operative knee ROM

Full Information

First Posted
May 25, 2021
Last Updated
May 28, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04906538
Brief Title
Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique
Official Title
Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
Rolimeter, ACLR, internal suture augmentation, IKDC score, Lysholm score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anterior cruciate ligament reconstruction with internal suture augmentation technique
Arm Type
Active Comparator
Arm Description
This group will be operated by using all-inside ACLR technique with internal suture augmentation technique
Arm Title
anterior cruciate ligament reconstruction without internal suture augmentation technique
Arm Type
Active Comparator
Arm Description
This group will be operated by using all-inside ACLR technique without internal suture augmentation technique
Intervention Type
Procedure
Intervention Name(s)
all- inside anterior cruciate ligament reconstruction
Intervention Description
all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique
Primary Outcome Measure Information:
Title
Lachmeter examination
Description
objective measurement of knee laxity
Time Frame
9 months
Title
Lysholm score
Description
subjective knee functional score (0 - 100) score. 100 is better in function
Time Frame
9 months
Title
International Knee Documentation score (IKDC) score
Description
subjective knee functional score (0 - 100) score. 100 is better in function
Time Frame
9 months
Secondary Outcome Measure Information:
Title
knee ROM
Description
post- operative knee ROM
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Khater, MD
Organizational Affiliation
Professor of orthopedic surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
study protocol and abstract
Citations:
PubMed Identifier
29442181
Citation
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.
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Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique

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