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

July 25, 2023 updated by: Joseph E. Broyles
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented Microdrilling Surgery
Procedure: Microdrilling Surgery
All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
Procedure: Injections of BMAC + PRP + HA
All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in International Knee Documentation Committee (IKDC) score
Time Frame: Change from baseline at 5 years post-operatively
Change from baseline at 5 years post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint Space Changes
Time Frame: 2 and 5 years post-operatively
Evaluated by plain radiographs
2 and 5 years post-operatively
MRI appearance of repair cartilage
Time Frame: 2 and 5 years post-operatively
Evaluated using the MOCART scoring system
2 and 5 years post-operatively
Frequency of adverse events requiring additional procedures
Time Frame: Continuously for 5 years post-operatively
Continuously for 5 years post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph E. Broyles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

February 15, 2019

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimated)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMPRP1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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