Clinical trial NCT04906538: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Rolimeter
ACLR
internal suture augmentation
IKDC score
Lysholm score
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Lachmeter examination
timeFrame: 9 months
measure: Lysholm score
timeFrame: 9 months
measure: International Knee Documentation score (IKDC) score
timeFrame: 9 months
Secondary outcomes:
measure: knee ROM
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Professor of orthopedic surgery
name: Ahmed A Khater, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.