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

ACL Clinical Trial

Official title:

The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533880
• Other study ID #: 20-00081
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: July 7, 2023

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACL

Intervention

Device:
• DBM
Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
• 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

Locations

Country	Name	City	State
United States	NYU Langone Orthopedic Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Score on International Knee Documentation Committee (IKDC Questionnaire)	The IKDC is a 10-item questionnaire evaluating knee function and symptoms. The IKDC is graded by adding the results of each item's scores, and then converting the result to a scale from 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).	Month 12 Post-Op
Primary	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 0-10; the higher the score, the worse the pain.	Month 12 Post-Op