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

NCT04533880 | Completed Results FDA Device

• 1 other identifier: 20-00081
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, Month 12 Post-Op

Study Arms (3)

Control

PLACEBO COMPARATOR

The control group will receive autologous bone obtained from the BTBPB graft harvest

Other: Autologous bone graft

Autologous Bone + DBM

ACTIVE COMPARATOR

Autologous bone plus demineralized bone matrix

Device: DBM; Other: Autologous bone graft

Autologous Bone + Calcium Phosphate Cement

ACTIVE COMPARATOR

Autologous bone plus calcium phosphate cement

Device: Calcium phosphate cement; Other: Autologous bone graft

Interventions

DBM DEVICE

Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)

Autologous Bone + DBM

Calcium phosphate cement DEVICE

Quickset, Arthrex, Naples, FL

Autologous Bone + Calcium Phosphate Cement

Autologous bone graft OTHER

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

Autologous Bone + Calcium Phosphate Cement; Autologous Bone + DBM; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Orthopedic Hospital

New York, New York, 10003, United States

Location

Results Point of Contact

• Title: Larry Chen
• Organization: NYU Langone Health

Larry.Chen@nyulangone.org

(646) 501-7200

Study Officials

• Eric Strauss, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: August 31, 2020
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)