← Back to Search

Procedure

Bone Grafting for ACL Reconstruction

N/A
Recruiting
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op month 24
Awards & highlights

Study Summary

This trial will test whether or not filling the harvest site defect is associated with a lower rate of donor site morbidity and better patient reported functional outcomes compared to patients whose harvest site remains unfilled.

Who is the study for?
This trial is for adults of any age who need primary ACL reconstruction using their own bone-patellar tendon-bone graft. They must be willing to participate in the study and have no prior knee surgeries, ligament or cartilage damage, or history of knee pain.Check my eligibility
What is being tested?
The study aims to see if filling the holes left after harvesting a patient's own tissue for ACL repair with autologous bone grafting reduces post-operative knee pain compared to leaving them unfilled.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site where bone was taken (donor site), increased risk of osteoarthritis, loss of sensation around the area, difficulty kneeling, and general complications from surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-op month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-op month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Direct Palpation of Harvest Site
Pain
Visual Analog Scale
Secondary outcome measures
International Knee Documentation Committee (IKDC) Subjective form
Knee
Marx Activity Scale
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Autologous Bone GraftingActive Control1 Intervention
Excess bone obtained from graft preparation and the coring reamer will be used to fill the patellar and tibial donor sites.
Group II: ControlPlacebo Group1 Intervention
The control group will have their patellar and tibial defects remain unfilled.

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
133 Previous Clinical Trials
18,870 Total Patients Enrolled

Media Library

Autologous bone grafting (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04958733 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Autologous Bone Grafting, Control
Anterior Cruciate Ligament Injury Clinical Trial 2023: Autologous bone grafting Highlights & Side Effects. Trial Name: NCT04958733 — N/A
Autologous bone grafting (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958733 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants being welcomed for this experiment?

"Yes, according to clinicaltrials.gov's published data, this research is actively inviting participants with the trial having been initially posted on September 3rd 2021 and last updated on August 3rd 2022. The investigators are hoping to recruit 60 volunteers from across three different medical sites."

Answered by AI

How many participants is this clinical trial accommodating?

"Affirmative. Clinicaltrials.gov displays that this clinical investigation, listed on September 3rd 2021, is actively hunting for participants. 60 individuals are being sought across 3 distinct healthcare facilities."

Answered by AI

What is the primary aim of this experiment?

"The main goal of this study, measured over a 24-month period post-operation, is to analyze pain with kneeling. Secondary objectives include evaluating Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) – an 11 item patient reported outcome ranging from 0 to 4 points - Marx Activity Scale – a four question survey concerning running, cutting, deceleration and pivoting activities that can award up to 16 points - and International Knee Documentation Committee (IKDC) Subjective form which assesses knee specific functional abilities on a scale from 0 to 100."

Answered by AI
Recent research and studies
~17 spots leftby Mar 2025