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Procedure

Bone Grafting for ACL Reconstruction

N/A
Waitlist Available
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
Must not have
Prior history of anterior knee pain or patellofemoral joint pain on the index knee
Concomitant ligamentous or chondral injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op month 24
Awards & highlights

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had pain in the front of my knee or kneecap before.
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I have a ligament or cartilage injury alongside my main condition.
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I have had surgery on my knee before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Direct Palpation of Harvest Site
Pain
Visual Analog Scale
Secondary study objectives
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
138 Previous Clinical Trials
19,337 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
~15 spots leftby Sep 2025
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