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

Sponsor
NYU Langone Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04533880
Collaborator
(none)
149
Enrollment
1
Location
3
Arms
36
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: DBM
  • Device: Calcium phosphate cement
  • Other: Autologous bone graft
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
149 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 :
Aug 31, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Score on Knee injury and Osteoarthritis Outcome Score (KOOS) Survey [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) [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Orthopedic Hospital New York New York United States 10003

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Eric Strauss, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04533880
Other Study ID Numbers:
  • 20-00081
First Posted:
Sep 1, 2020
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Calcium

Study Results

No Results Posted as of Aug 24, 2022