N/A
N=150
The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction
ACL
Bottom Line
View on ClinicalTrials.gov: NCT04533880 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey — 67; 69; 67.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DBM (Device); Calcium phosphate cement (Device); Autologous bone graft (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey |
67; 69; 67.7 | — |
| PRIMARY Score on Kujala Anterior Knee Pain Scale (AKPS) |
87.1; 85.7; 86.2 | — |
| PRIMARY Change in VAS Score for Anterior Knee Pain |
-5.5; -8.4; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04533880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.