Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique

Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique: Prospective Cohort Study

this study was to evaluate the functional outcome of quadruple hamstring graft in femoral tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and clinical evaluation between short and normal femoral tunnel graft length of hamstring tendon ACL reconstruction.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Procedure: Anatomic anterior cruciate ligament with short hamstring graft technique; Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft technique

Detailed Description

The patient recruitment (N=29) and baseline data collection were done at our institute between March2014-September 2015. The inclusion criteria were patients with anterior cruciate ligamentous injury who needed ligamentous reconstruction, closed growth plates and younger than 60 years old, absence of ligament injury to the opposite knee. The exclusion criteria are patients who did not want to participate in this study or patient with failed anterior cruciate ligamentous reconstruction.

All the procedure of anterior cruciate ligament reconstructions were performed by the senior authors (B.C). Semitendinosus and gracilis tendons were harvested through an oblique approach medial to the tibial tubercle in all patients. Complete anterior cruciate ligament was confirmed at arthroscopy. Associated intra-articular injuries such as meniscus tear and cartilage lesions were fixed at of the index operation .The femoral tunnel were drilled though the AM portal.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with anterior cruciate ligamentous injury with the diagnosis of injured ligaments was made based on a detailed history of the knee injury, physical examination on pathologic status and abnormal laxity, routinely performed plain radiographs and MRI scans, and the findings at surgery.
• Patients who have closed growth plates.
• Patients who younger than 60 years old.
• Patients who absence of ligament injury to the opposite knee.

Exclusion Criteria:

• Patients with a combined ligament injury as folling:

  1. Posterior cruciate ligament
  2. The lateral collateral ligament
  3. The posterolateral corner structures of the knee
  4. Medial collateral ligament.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anatomic anterior cruciate ligament with short hamstring; Anatomic anterior cruciate ligament with short hamstring graft	Procedure: Anatomic anterior cruciate ligament with short hamstring graft technique; ACL and short hamstring graft
Active Comparator: Anatomic anterior cruciate ligament with standard hamstring; Anatomic anterior cruciate ligament with standard hamstring graft	Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft technique; ACL with standard hamstring graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog score	visual analog score rang from 0-10 (minimum=0, maximun=10) and the higher values represent a worse outcome?)	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	range of motion range from 0-160 degree and the higher values represent a better outcome	18 months
complication	number of participant who have infection, stiffness and re-operation	18 months

Collaborators and Investigators

• Sponsor: Ramathibodi Hospital
• Collaborators: Thammasat University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ACL; short hamstring graft; standard hamstring graft
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: MTU-EC-OT-0-255-61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No