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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | The control group will receive autologous bone obtained from the BTBPB graft harvest |
|
| Autologous Bone + DBM | Active Comparator | Autologous bone plus demineralized bone matrix |
|
| Autologous Bone + Calcium Phosphate Cement | Active Comparator | Autologous bone plus calcium phosphate cement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBM | Device | Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. The total score is the sum of responses; total scores range from 0 to 100. Lower scores indicate greater signs of knee pain. | Month 12 Post-Op |
| 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. | Baseline, Month 12 Post-Op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Strauss, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Orthopedic Hospital | New York | New York | 10003 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to eric.strauss@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Autologous Bone + DBM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Op |
|
12 months post-operation.
Adverse event information collected at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry Chen | NYU Langone Health | (646) 501-7200 | Larry.Chen@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2020 | Jul 15, 2024 | Prot_SAP_000.pdf |
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| Calcium phosphate cement | Device | Quickset, Arthrex, Naples, FL |
|
| Autologous bone graft | Other | Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft |
|
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
| OG002 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Op |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 12 Post-Op |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | 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 | 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | 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 | 0 | 47 | 0 | 47 | 0 | 47 |
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