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The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT04533880
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.


Condition or disease Intervention/treatment Phase
ACL Device: DBM Device: Calcium phosphate cement Other: Autologous bone graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

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Arm Intervention/treatment
Placebo Comparator: Control
The control group will receive autologous bone obtained from the BTBPB graft harvest
Other: Autologous bone graft
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft

Active Comparator: Autologous Bone + DBM
Autologous bone plus demineralized bone matrix
Device: DBM
Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)

Other: Autologous bone graft
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft

Active Comparator: Autologous Bone + Calcium Phosphate Cement
Autologous bone plus calcium phosphate cement
Device: Calcium phosphate cement
Quickset, Arthrex, Naples, FL

Other: Autologous bone graft
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft




Primary Outcome Measures :
  1. Score on Knee injury and Osteoarthritis Outcome Score (KOOS) Survey [ Time Frame: Month 12 Post-Op ]
    The KOOS survery is comprised of 42 questions. The 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). 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.

  2. 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. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). Total scores range from 0 to 100. The lower the score, the better.

  3. Score on International Knee Documentation Committee (IKDC Questionnaire) [ Time Frame: Month 12 Post-Op ]
    The IKDC contains 2 quantitatively measurable questions. Each question is scored 0-10, for a total range of 0-20. The higher the score, the more pain was experienced.

  4. VAS Score for Anterior Knee Pain [ Time Frame: 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 0-10; the higher the score, the worse the pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533880


Contacts
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Contact: Eric Strauss, MD 646-501-7223 eric.strauss@nyulangone.org
Contact: Eoghan Hurley, MB, BCh, MCh 646-501-7223 eoghan.hurley@nyulangone.org

Locations
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United States, New York
NYU Langone Orthopedic Hospital Recruiting
New York, New York, United States, 10003
Contact: Eric Strauss, MD    646-501-7223    eric.strauss@nyulangone.org   
Contact: Eoghan Hurley, MB, BCh, MCh    6465017223    eoghan.hurley@nyulangone.org   
Principal Investigator: Eric Strauss, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Eric Strauss, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04533880    
Other Study ID Numbers: 20-00081
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs