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

Osteoarthritis Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285725
• Other study ID #: BMPRP1001
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2023
• Source: Bone and Joint Clinic of Baton Rouge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Degeneration; Articular Cartilage, Knee
• Degenerative Lesion of Articular Cartilage of Knee
• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee
• Unilateral Primary Osteoarthritis of Knee

Intervention

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)
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Joseph E. Broyles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in International Knee Documentation Committee (IKDC) score		Change from baseline at 5 years post-operatively
Secondary	Joint Space Changes	Evaluated by plain radiographs	2 and 5 years post-operatively
Secondary	MRI appearance of repair cartilage	Evaluated using the MOCART scoring system	2 and 5 years post-operatively
Secondary	Frequency of adverse events requiring additional procedures		Continuously for 5 years post-operatively

External Links

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