The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction

Brief Title

The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction

Official Title

The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft

Brief Summary

      One of the common complaints after ACLR with BPTB autograft anterior knee pain. It is thought
      that this may be due to harvesting the patellar tendon for graft use. Specifically, this may
      be due to the bone defect that is left after graft harvesting. There is currently no
      consensus on a gold standard for treating the bone defect with surgeons using multiple
      commercially available bone void fillers as well as autologous bone graft in standard
      practice.

      The purpose of the proposed study is to evaluate the effect bone-void filler on anterior knee
      pain following ACL reconstruction BPTB autograft.
    



Study Type

Interventional


Primary Outcome

Score on Knee injury and Osteoarthritis Outcome Score (KOOS) Survey


Condition

ACL

Intervention

DBM

Study Arms / Comparison Groups

 Control
Description:  The control group will receive autologous bone obtained from the BTBPB graft harvest

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

120

Start Date

August 31, 2020

Completion Date

September 1, 2022

Primary Completion Date

September 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients undergoing ACLR with BPTB autograft

          -  Skeletally mature (as defined by closed growth plates on plain radiograph)

          -  At least 18 years of age

          -  Willing and able to provide consent

        Exclusion Criteria:

          -  knee with intact ACL

          -  skeletally immature (as defined by open physis on plain radiograph)

          -  pregnant

          -  less than 18 years of age

          -  previous ACL repair or reconstruction

          -  unable to speak english or perform informed consent

          -  multiligamentous knee injury (two or more ligaments requiring surgical attention)

          -  varus or valgus malalignment greater than 3 degrees
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Eric Strauss, MD, 646-501-7223, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04533880

Organization ID

20-00081


Responsible Party

Sponsor

Study Sponsor

NYU Langone Health


Study Sponsor

Eric Strauss, MD, Principal Investigator, NYU Langone Health


Verification Date

September 2020