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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906538
• Other study ID #: FMASU MD 310 2018
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 1, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lachmeter examination	objective measurement of knee laxity	9 months
Primary	Lysholm score	subjective knee functional score (0 - 100) score. 100 is better in function	9 months
Primary	International Knee Documentation score (IKDC) score	subjective knee functional score (0 - 100) score. 100 is better in function	9 months
Secondary	knee ROM	post- operative knee ROM	9 months