Bone Graft; ComplicationsBTB BackFillNCT06975306
Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
A study testing autologous bone grafts and Demineralized bone matrix (DBM) in people with Bone Graft; Complications and ACL Injuries, run by University of Arizona at 3 sites in United States.
Trial summary
All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bone Graft; Complications, ACL Injuries
- What is being tested?
- autologous bone grafts and Demineralized bone matrix (DBM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Feb 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years old,
- male/female/gender neutral,
- all races not including vulnerable/special consideration populations,
- candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,
- compliant post operative course.
Who cannot join
- < 18, >41 years of age,
- prior bone patellar bone anterior cruciate ligament reconstruction,
- non-compliance post-operatively,
- nicotine dependence.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Phoenix Biomedical Campus Regulatory Team contact
United States3 sites, 3 recruiting
- Recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Marleny Munoz, 602-793-9582, marlenymunoz@arizona.edu
- Recruiting
Banner Health Center Plus - Arcadia
Phoenix, Arizona, 85008
Marleny Munoz, 602-793-9582, marlenymunoz@arizona.edu
- Recruiting
Banner Sports Medicine Scottsdale
Scottsdale, Arizona, 85256
Marleny Munoz, 602-793-9582, marlenymunoz@arizona.edu
About this study
All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.
- Conditions
- Bone Graft; Complications, ACL Injuries
- Being tested
- autologous bone grafts, Demineralized bone matrix (DBM)
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone graftsProcedure or surgery
group will be treated with autologous bone graft for BTB ACLR
Demineralized bone matrix (DBM)Other
Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors.
| Study group | Role | What they receive |
|---|---|---|
| autologous bone graft | Experimental | One group will be treated with autologous bone graft for BTB ACLR Receives: Procedure: autologous bone grafts |
| Demineralized bone matrix (DBM) putty | Experimental | Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors. Receives: Other: Demineralized bone matrix (DBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in surgical time
Measured: Duration of Procedure
Change in number of complications from the coring reamer intra-operatively
Measured: Duration of Procedure
Change in number of complications associated with displacement of the bone graft
Measured: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale
Measured: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System
Measured: 1 year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start11 Feb 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bone Graft; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anup Shah, University of Arizona
- Investigators
- Anup Shah, MD, Principal investigator, College of Medicine - Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975306
- Sponsor's protocol ID
- STUDY00005122
- Acronym
- BTB BackFill
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schandl K, Horvathy DB, Doros A, Majzik E, Schwarz CM, Csonge L, Abkarovits G, Bucsi L, Lacza Z. Bone-Albumin filling decreases donor site morbidity and enhances bone formation after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Int Orthop. 2016 Oct;40(10):2097-2104. doi: 10.1007/s00264-016-3246-8. Epub 2016 Jun 29.
PubMed 27357530Zhang H, Yang L, Yang XG, Wang F, Feng JT, Hua KC, Li Q, Hu YC. Demineralized Bone Matrix Carriers and their Clinical Applications: An Overview. Orthop Surg. 2019 Oct;11(5):725-737. doi: 10.1111/os.12509. Epub 2019 Sep 8.
PubMed 31496049Leafblad ND, Maak TG. Bone Grafting Technique in Revision ACL Reconstruction: Coring Reamer and Dowel Trick. Arthrosc Tech. 2022 Jun 21;11(7):e1367-e1372. doi: 10.1016/j.eats.2022.03.024. eCollection 2022 Jul.
PubMed 35936861Tsuda E, Okamura Y, Ishibashi Y, Otsuka H, Toh S. Techniques for reducing anterior knee symptoms after anterior cruciate ligament reconstruction using a bone-patellar tendon-bone autograft. Am J Sports Med. 2001 Jul-Aug;29(4):450-6. doi: 10.1177/03635465010290041201.
PubMed 11476385Radiological Society of North America (RSNA) and American College of Radiology (ACR). (2022, November 1). Radiation Dose. Radiologyinfo.org. https://www.radiologyinfo.org/en/info/safety-xrayMedical research
J. M. Erdal, I. Vik, a. P. Parkar; Bergen/NO & European Society of Radiology. (n.d.). Assessment of effective dose in a series of CT of the knees, time to revise the guidelines? In EPOS. ECR 2016. https://dx.doi.org/10.1594/ecr2016/C-0205
Su AW, Hillen TJ, Eutsler EP, Bedi A, Ross JR, Larson CM, Clohisy JC, Nepple JJ. Low-Dose Computed Tomography Reduces Radiation Exposure by 90% Compared With Traditional Computed Tomography Among Patients Undergoing Hip-Preservation Surgery. Arthroscopy. 2019 May;35(5):1385-1392. doi: 10.1016/j.arthro.2018.11.013. Epub 2019 Apr 12.
PubMed 30987906
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
- ClinicalTrials.gov ID
- NCT06975306
- Acronym / sponsor ID
- BTB BackFill / STUDY00005122
- Conditions
- Bone Graft; Complications, ACL Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous bone graft | Experimental | Procedure: autologous bone graftsOne group will be treated with autologous bone graft for BTB ACLR |
| Demineralized bone matrix (DBM) putty | Experimental | Other: Demineralized bone matrix (DBM)Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-40 years old,
- male/female/gender neutral,
- all races not including vulnerable/special consideration populations,
- candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,
- compliant post operative course.
Key exclusion criteria (4 listed)
- < 18, >41 years of age,
- prior bone patellar bone anterior cruciate ligament reconstruction,
- non-compliance post-operatively,
- nicotine dependence.
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 |
|---|---|---|
| autologous bone graftsgroup will be treated with autologous bone graft for BTB ACLR | Procedure or surgery | autologous bone graft |
| Demineralized bone matrix (DBM)Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors. | Other | Demineralized bone matrix (DBM) putty |
Primary outcome
change in surgical time
Time frame: Duration of Procedure
Change in number of complications from the coring reamer intra-operatively
Time frame: Duration of Procedure
Change in number of complications associated with displacement of the bone graft
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 27357530Schandl K, Horvathy DB, Doros A, Majzik E, Schwarz CM, Csonge L, Abkarovits G, Bucsi L, Lacza Z. Bone-Albumin filling decreases donor site morbidity and enhances bone formation after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Int Orthop. 2016 Oct;40(10):2097-2104. doi: 10.1007/s00264-016-3246-8. Epub 2016 Jun 29.
- Background: PubMed 31496049Zhang H, Yang L, Yang XG, Wang F, Feng JT, Hua KC, Li Q, Hu YC. Demineralized Bone Matrix Carriers and their Clinical Applications: An Overview. Orthop Surg. 2019 Oct;11(5):725-737. doi: 10.1111/os.12509. Epub 2019 Sep 8.
- Background: PubMed 35936861Leafblad ND, Maak TG. Bone Grafting Technique in Revision ACL Reconstruction: Coring Reamer and Dowel Trick. Arthrosc Tech. 2022 Jun 21;11(7):e1367-e1372. doi: 10.1016/j.eats.2022.03.024. eCollection 2022 Jul.
- Background: PubMed 11476385Tsuda E, Okamura Y, Ishibashi Y, Otsuka H, Toh S. Techniques for reducing anterior knee symptoms after anterior cruciate ligament reconstruction using a bone-patellar tendon-bone autograft. Am J Sports Med. 2001 Jul-Aug;29(4):450-6. doi: 10.1177/03635465010290041201.
- BackgroundRadiological Society of North America (RSNA) and American College of Radiology (ACR). (2022, November 1). Radiation Dose. Radiologyinfo.org. https://www.radiologyinfo.org/en/info/safety-xrayMedical research
- BackgroundJ. M. Erdal, I. Vik, a. P. Parkar; Bergen/NO & European Society of Radiology. (n.d.). Assessment of effective dose in a series of CT of the knees, time to revise the guidelines? In EPOS. ECR 2016. https://dx.doi.org/10.1594/ecr2016/C-0205
- Background: PubMed 30987906Su AW, Hillen TJ, Eutsler EP, Bedi A, Ross JR, Larson CM, Clohisy JC, Nepple JJ. Low-Dose Computed Tomography Reduces Radiation Exposure by 90% Compared With Traditional Computed Tomography Among Patients Undergoing Hip-Preservation Surgery. Arthroscopy. 2019 May;35(5):1385-1392. doi: 10.1016/j.arthro.2018.11.013. Epub 2019 Apr 12.
- Individual participant dataSharing planned: No
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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.
Phoenix Biomedical Campus Regulatory Team contact
Anup Shah, MD principal investigator
College of Medicine - Phoenix
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous bone grafts and Demineralized bone matrix (DBM) in people with Bone Graft; Complications and ACL Injuries, run by University of Arizona at 3 sites 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marleny Munoz (602-793-9582, marlenymunoz@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in surgical time (time frame: Duration of Procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06975306, which also lists 7 linked publications.
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 14 Aug 2026.