ACL
Conditions
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.
Interventions
DEVICEDBM
Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
DEVICECalcium phosphate cement
Quickset, Arthrex, Naples, FL
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey | Month 12 Post-Op | The KOOS survery comprises 42 questions; 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). Each item is rated on a Likert scale from 0 to 4. The score is calculated by summing the responses. 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. |
| Score on Kujala Anterior Knee Pain Scale (AKPS) | Month 12 Post-Op | 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. The total score is the sum of responses; total scores range from 0 to 100. Lower scores indicate greater signs of knee pain. |
| Change in VAS Score for Anterior Knee Pain | Baseline, Month 12 Post-Op | 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 0-100; the higher the score, the worse the pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft | 52 |
| Autologous Bone + DBM Autologous bone plus demineralized bone matrix
DBM: Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft | 49 |
| Autologous Bone + Calcium Phosphate Cement Autologous bone plus calcium phosphate cement
Calcium phosphate cement: Quickset, Arthrex, Naples, FL
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft | 47 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Autologous Bone + Calcium Phosphate Cement | Autologous Bone + DBM |
|---|---|---|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 6.8 | 28.43 years STANDARD_DEVIATION 7.13 | 28.8 years STANDARD_DEVIATION 6.5 | 28.8 years STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 52 Participants | 148 Participants | 47 Participants | 49 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 52 participants | 148 participants | 47 participants | 49 participants |
| Sex: Female, Male Female | 18 Participants | 71 Participants | 27 Participants | 26 Participants |
| Sex: Female, Male Male | 34 Participants | 77 Participants | 20 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 49 | 0 / 47 |
| other Total, other adverse events | 0 / 52 | 0 / 49 | 0 / 47 |
| serious Total, serious adverse events | 0 / 52 | 0 / 49 | 0 / 47 |
Outcome results
Primary
Change in 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 0-100; the higher the score, the worse the pain.
Time frame: Baseline, Month 12 Post-Op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in VAS Score for Anterior Knee Pain | -5.5 score on a scale | Standard Deviation 24.3 |
| Autologous Bone + DBM | Change in VAS Score for Anterior Knee Pain | -8.4 score on a scale | Standard Deviation 26.9 |
| Autologous Bone + Calcium Phosphate Cement | Change in VAS Score for Anterior Knee Pain | 1 score on a scale | Standard Deviation 26.4 |
Primary
Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey
The KOOS survery comprises 42 questions; 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). Each item is rated on a Likert scale from 0 to 4. The score is calculated by summing the responses. 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.
Time frame: Month 12 Post-Op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey | 67 score on a scale | Standard Deviation 6.1 |
| Autologous Bone + DBM | Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey | 69 score on a scale | Standard Deviation 6.3 |
| Autologous Bone + Calcium Phosphate Cement | Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey | 67.7 score on a scale | Standard Deviation 8.2 |
Primary
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. The total score is the sum of responses; total scores range from 0 to 100. Lower scores indicate greater signs of knee pain.
Time frame: Month 12 Post-Op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Score on Kujala Anterior Knee Pain Scale (AKPS) | 87.1 score on a scale | Standard Deviation 11 |
| Autologous Bone + DBM | Score on Kujala Anterior Knee Pain Scale (AKPS) | 85.7 score on a scale | Standard Deviation 17 |
| Autologous Bone + Calcium Phosphate Cement | Score on Kujala Anterior Knee Pain Scale (AKPS) | 86.2 score on a scale | Standard Deviation 12.1 |