CompletedNot Applicable

Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid

21 participantsStarted 2011-03

Plain-language summary

This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis. Exclusion Criteria: * Inflammatory arthritis * Body mass index (BMI) greater than 35 * Presence of significant varus or valgus knee instability or unusually stiff knee * Greater than 50% deviation of the mechanical axis * Presence of active cardiac disease * Presence of active pulmonary disease * Prior septic arthritis of the involved joint * Presence of active bacterial or Mycobacterial infection * Presence of a known hypercoagulable state * Pregnant or lactating females * Subject known to be positive for hepatitis B, hepatitis C, or HIV * Known allergy to hyaluronic acid * Patients who are unable or unwilling to participate fully in post-operative physical therapy * Patients with a contraindication to MRI scanning * Any disorder that compromises ability to give consent or comply with study procedures * Patients who are felt to be at significantly increased risk for elective orthopedic surgery * Non-ambulatory patients * Patients with cognitive impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in International Knee Documentation Committee (IKDC) score

Timeframe: Change from baseline at 5 years post-operatively

Trial details

NCT IDNCT02285725

SponsorJoseph E. Broyles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-15

View on ClinicalTrials.gov More Unilateral Primary Osteoarthritis of Knee trials