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Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT02833454
Recruitment Status : Unknown
Verified July 2016 by Jia-kuo yu, Peking University Third Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2016
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Jia-kuo yu, Peking University Third Hospital

Brief Summary:
The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.

Condition or disease Intervention/treatment Phase
Rupture of Anterior Cruciate Ligament Procedure: direct insertion anterior cruciate ligament reconstruction Procedure: single bundle anterior cruciate ligament reconstruction Procedure: double bundle anterior cruciate ligament reconstruction Not Applicable

Detailed Description:
The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: direct insertion single bundle ACLR
Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.
Procedure: direct insertion anterior cruciate ligament reconstruction
ACL reconstruction based on direct insertion of ACL.

Procedure: single bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using single bundle technique

Experimental: anatomical double bundle ACLR
Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction.
Procedure: double bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using double bundle technique

Experimental: anatomical single bundle ACLR
Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction.
Procedure: single bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using single bundle technique

Active Comparator: direct insertion double bundle ACLR
Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.
Procedure: direct insertion anterior cruciate ligament reconstruction
ACL reconstruction based on direct insertion of ACL.

Procedure: double bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using double bundle technique




Primary Outcome Measures :
  1. Lysholm score of the knee [ Time Frame: two years ]

    Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .

    Scale name:score


  2. Tegner score of the knee [ Time Frame: two years ]

    Tegner score of the knee was evaluated preoperatively and at 2 years post operation .

    Scale name:score


  3. IKDC score of the knee [ Time Frame: two years ]

    IKDC score of the knee was evaluated preoperatively and at 2 years post operation .

    Scale name:score



Secondary Outcome Measures :
  1. KT-2000 of the knee [ Time Frame: two years ]
    KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.



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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACL rupture patients aged between 16 to 40 years

Exclusion Criteria:

  • combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation)
  • any injury or surgery to the contralateral knee
  • any infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833454


Contacts
Contact: Yu Jia-Kuo, MD 86-10-82267392 yujiakuo@126.com
Contact: Liu Yang, MD 86-10-82267019 surgeonliuyang@sina.com

Sponsors and Collaborators
Peking University Third Hospital
Investigators
Study Chair: Jia-Kuo Yu, MD Peking University Third Hospital

Responsible Party: Jia-kuo yu, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT02833454     History of Changes
Other Study ID Numbers: DACL-1
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016

Keywords provided by Jia-kuo yu, Peking University Third Hospital:
Anterior Cruciate Ligament Reconstruction
Direct Insertion of Anterior Cruciate Ligament

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