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Recruiting NCT06975306

Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction

No phase Interventional Bone Graft; Complications ACL Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: autologous bone grafts, Demineralized bone matrix (DBM).
Who it may be relevant to
Registry conditions: Bone Graft; Complications, ACL Injuries. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure autologous bone grafts
    group will be treated with autologous bone graft for BTB ACLR
  • 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.

Primary outcome measures

  • 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 [Time frame: 1 year post procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • < 18, >41 years of age,
  • prior bone patellar bone anterior cruciate ligament reconstruction,
  • non-compliance post-operatively,
  • nicotine dependence.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Banner University Medical Center Phoenix — Phoenix
  • Banner Health Center Plus - Arcadia — Phoenix
  • Banner Sports Medicine Scottsdale — Scottsdale

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. PMID 27357530
  • Zhang 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. PMID 31496049
  • Leafblad 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. PMID 35936861
  • Tsuda 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. PMID 11476385
  • Radiological 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. PMID 30987906

Identifiers

NCT: NCT06975306 · STUDY00005122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗