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