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

NYU Langone Health

Status: Completed

Conditions: ACL

Treatments: Device: Calcium phosphate cement; Other: Autologous bone graft; Device: DBM

Study type: Interventional

Funder types: Other

Identifiers

NCT04533880

20-00081

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Autologous bone graft

Autologous Bone + DBM

Active Comparator group

Description:

Autologous bone plus demineralized bone matrix

Treatment:

Device: DBM

Other: Autologous bone graft

Autologous Bone + Calcium Phosphate Cement

Active Comparator group

Description:

Autologous bone plus calcium phosphate cement

Treatment:

Other: Autologous bone graft

Device: Calcium phosphate cement