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

Study Overview
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Brief Summary
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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.

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

Conditions
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ACL

Intervention / Treatment
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* Device: DBM
* Device: Calcium phosphate cement
* Other: Autologous bone graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>The control group will receive autologous bone obtained from the BTBPB graft harvest | Other: Autologous bone graft<br>* Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft<br>|
| Active Comparator: Autologous Bone + DBM<br>Autologous bone plus demineralized bone matrix | Device: DBM<br>* Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)<br>Other: Autologous bone graft<br>* Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft<br>|
| Active Comparator: Autologous Bone + Calcium Phosphate Cement<br>Autologous bone plus calcium phosphate cement | Device: Calcium phosphate cement<br>* Quickset, Arthrex, Naples, FL<br>Other: Autologous bone graft<br>* Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Knee injury and Osteoarthritis Outcome Score (KOOS) Survey | The KOOS survery is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain / higher difficulty in function. | Month 12 Post-Op | 
| Score on Kujala Anterior Knee Pain Scale (AKPS) | The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). Total scores range from 0 to 100. The lower the score, the better. | Month 12 Post-Op | 
| Score on International Knee Documentation Committee (IKDC Questionnaire) | The IKDC contains 2 quantitatively measurable questions. Each question is scored 0-10, for a total range of 0-20. The higher the score, the more pain was experienced. | Month 12 Post-Op | 
| VAS Score for Anterior Knee Pain | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. The total score range is 0-10; the higher the score, the worse the pain. | Month 12 Post-Op |