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

NYU Langone Health logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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