ACLNCT04533880
The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction
A study testing DBM, Calcium phosphate cement and Autologous bone graft in people with ACL, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ACL
- What is being tested?
- DBM, Calcium phosphate cement and Autologous bone graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Orthopedic Hospital
New York, New York, 10003
About this study
Official title: The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft
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.
- Conditions
- ACL
- Being tested
- DBM, Calcium phosphate cement, Autologous bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBMDevice
Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Calcium phosphate cementDevice
Quickset, Arthrex, Naples, FL
Autologous bone graftOther
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The control group will receive autologous bone obtained from the BTBPB graft harvest Receives: Other: Autologous bone graft |
| Autologous Bone + DBM | Active comparator | Autologous bone plus demineralized bone matrix Receives: Device: DBM; Other: Autologous bone graft |
| Autologous Bone + Calcium Phosphate Cement | Active comparator | Autologous bone plus calcium phosphate cement Receives: Device: Calcium phosphate cement; Other: Autologous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 12 Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start31 Aug 2020
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ACLStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Strauss, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533880
- Sponsor's protocol ID
- 20-00081
- Status last verified
- Jul 2024
- First submitted
- 27 Aug 2020
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft
- ClinicalTrials.gov ID
- NCT04533880
- Acronym / sponsor ID
- 20-00081
- Conditions
- ACL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Autologous bone graftThe control group will receive autologous bone obtained from the BTBPB graft harvest |
| Autologous Bone + DBM | Active comparator | Device: DBM, Other: Autologous bone graftAutologous bone plus demineralized bone matrix |
| Autologous Bone + Calcium Phosphate Cement | Active comparator | Device: Calcium phosphate cement, Other: Autologous bone graftAutologous bone plus calcium phosphate cement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBMDemineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL) | Device | Autologous Bone + DBM |
| Calcium phosphate cementQuickset, Arthrex, Naples, FL | Device | Autologous Bone + Calcium Phosphate Cement |
| Autologous bone graftAutologous bone grafting involves utilizing bone obtained from the same individual receiving the graft | Other | Autologous Bone + Calcium Phosphate Cement, Autologous Bone + DBM, Control |
Primary outcome
Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
Related trials for ACL
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Strauss, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBM, Calcium phosphate cement and Autologous bone graft in people with ACL, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey (time frame: Month 12 Post-Op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.