Overview

This trial is active, not recruiting.

Conditions unilateral primary osteoarthritis of knee, osteoarthritis knee, degeneration; articular cartilage, knee, degenerative lesion of articular cartilage of knee
Treatments microdrilling surgery, injections of bmac + prp + ha
Sponsor Joseph E. Broyles
Start date March 2011
End date December 2018
Trial size 21 participants
Trial identifier NCT02285725, BMPRP1001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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)
injections of bmac + prp + ha
All patients will receive up to 12 post-operative intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA (Supartz)

Primary Outcomes

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

Secondary Outcomes

Measure
Joint Space Changes
time frame: 2 and 5 years post-operatively
MRI appearance of repair cartilage
time frame: 2 and 5 years post-operatively
Frequency of adverse events requiring additional procedures
time frame: Continuously for 5 years post-operatively

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Bone and Joint Clinic of Baton Rouge.