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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: Anatomic anterior cruciate ligament with short hamstring graft technique; Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft technique

• Registration Number: NCT03954925
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2014-03-01
• Primary Completion: 2015-09-01
• Study Completion: 2019-03-01
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anatomic anterior cruciate ligament with short hamstring	Anatomic anterior cruciate ligament with short hamstring graft technique	Anatomic anterior cruciate ligament with short hamstring graft
Anatomic anterior cruciate ligament with standard hamstring	Anatomic anterior cruciate ligament with a standard hamstring graft technique	Anatomic anterior cruciate ligament with standard hamstring graft

Primary Outcome Measures

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

Secondary Outcome Measures

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