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Completed

NCT Number: NCT03954925

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Posterior cruciate ligament
  • The lateral collateral ligament
  • The posterolateral corner structures of the knee
  • Medial collateral ligament.

Treatment and study plan

Anatomic anterior cruciate ligament with short hamstring graft technique

Procedure

ACL and short hamstring graft

Anatomic anterior cruciate ligament with a standard hamstring graft technique

Procedure

ACL with standard hamstring graft

Primary outcomes

  1. Visual analog score

    Time frame: 18 months

    visual analog score rang from 0-10 (minimum=0, maximun=10) and the higher values represent a worse outcome?)

Secondary outcomes

  1. range of motion

    Time frame: 18 months

    range of motion range from 0-160 degree and the higher values represent a better outcome

  2. complication

    Time frame: 18 months

    number of participant who have infection, stiffness and re-operation

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • Thammasat University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2019
First posted
May 17, 2019
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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