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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 : June 20, 2019
Sponsor:
Collaborator:
Thammasat University
Information provided by (Responsible Party):
Jatupon Kongtharvonskul, Ramathibodi Hospital

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE March 1, 2014
Actual Primary Completion Date September 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
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?)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03954925 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • range of motion [ Time Frame: 18 months ]
    range of motion range from 0-160 degree and the higher values represent a better outcome
  • complication [ Time Frame: 18 months ]
    number of participant who have infection, stiffness and re-operation
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • range of motion [ Time Frame: 18 months ]
    range of motion range from 0-160 degree and the higher values represent a better outcome
  • complication [ Time Frame: 18 months ]
    complication included infection, stiffness, re-operation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique
Official Title  ICMJE Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique: Prospective Cohort Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Injuries
Intervention  ICMJE
  • Procedure: Anatomic anterior cruciate ligament with short hamstring graft technique
    ACL and short hamstring graft
  • Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft technique
    ACL with standard hamstring graft
Study Arms  ICMJE
  • Active Comparator: Anatomic anterior cruciate ligament with short hamstring
    Anatomic anterior cruciate ligament with short hamstring graft
    Intervention: Procedure: Anatomic anterior cruciate ligament with short hamstring graft technique
  • Active Comparator: Anatomic anterior cruciate ligament with standard hamstring
    Anatomic anterior cruciate ligament with standard hamstring graft
    Intervention: Procedure: Anatomic anterior cruciate ligament with a standard hamstring graft technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date September 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954925
Other Study ID Numbers  ICMJE MTU-EC-OT-0-255-61
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jatupon Kongtharvonskul, Ramathibodi Hospital
Study Sponsor  ICMJE Ramathibodi Hospital
Collaborators  ICMJE Thammasat University
Investigators  ICMJE Not Provided
PRS Account Ramathibodi Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP