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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954925
• Other study ID #: MTU-EC-OT-0-255-61
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: March 1, 2019

Study information

• Verified date: June 2019
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 1, 2019
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• Anatomic anterior cruciate ligament with short hamstring graft technique
ACL and short hamstring graft
• Anatomic anterior cruciate ligament with a standard hamstring graft technique
ACL with standard hamstring graft

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ramathibodi Hospital	Thammasat University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	range of motion	range of motion range from 0-160 degree and the higher values represent a better outcome	18 months
Secondary	complication	number of participant who have infection, stiffness and re-operation	18 months