Microdrilling Surgery for Full Thickness Chondral Lesions... | NCT02285725

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

NCT02285725

Sponsor

Joseph E. Broyles

Status

Completed

Last Update Posted

Jul 27, 2023Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

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

Interventions

Microdrilling Surgery
Injections of BMAC + PRP + HA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011Actual

Primary Completion Date

Feb 15, 2019Actual

Completion Date

Feb 15, 2019Actual

First Submitted Date

Oct 31, 2014

First Submission Date that Met QC Criteria

Nov 4, 2014

First Posted Date

Nov 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2023

Last Update Posted Date

Jul 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Augmented Microdrilling Surgery	Experimental		Procedure: Microdrilling Surgery Procedure: Injections of BMAC + PRP + HA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microdrilling Surgery	Procedure	All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Joint Space Changes	Evaluated by plain radiographs	2 and 5 years post-operatively
MRI appearance of repair cartilage	Evaluated using the MOCART scoring system

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Label	URL
Related Info	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases