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

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ClinicalTrials.gov Identifier: NCT03954925
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Thammasat University
Information provided by (Responsible Party):
Jatupon Kongtharvonskul, 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Procedure: Anatomic anterior cruciate ligament with short hamstring graft technique Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft technique Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique: Prospective Cohort Study
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : March 1, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    complication included infection, stiffness, re-operation



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

patients with anterior cruciate ligamentous injury; 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. Closed growth plates and younger than 60 years old, absence of ligament injury to the opposite knee

Exclusion Criteria:

Patients with a combined ligament injury in the posterior cruciate ligament, the lateral collateral ligament, the posterolateral corner structures of the knee, and medial collateral ligament.


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Responsible Party: Jatupon Kongtharvonskul, principle investigator, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT03954925     History of Changes
Other Study ID Numbers: MTU-EC-OT-0-255-61
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jatupon Kongtharvonskul, Ramathibodi Hospital:
ACL
short hamstring graft
standard hamstring graft

Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries