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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2019-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Treatment of Osteoarthritis of the Knee in the Form of Chondromalacia of the Articular Cartilage Treated in the Arthroscopic Technique With the Use of:Autogenous Transplantation of Fragmented Adipose Tissue,PRP GF,Mesenchymal Cells,Hyaluronic Acid-low Molecular Weight and Cross-linked

NCT07110402

Osteoarthritis, Knee Chondral Defect Chondromalacia, Left Knee +2 more

COMPLETED NA

Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip

NCT02183896

Femoroacetabular Impingement Chondral Lesions

WITHDRAWN NA

Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

NCT03101163

Articular Cartilage Disorder of Knee Articular Cartilage; Degeneration

COMPLETED PHASE2

PRP vs AD-SVF in Addition to Marrow Stimulation for Knee Chondral Lesion

NCT07255547

Knee Chondral Lesion

ACTIVE_NOT_RECRUITING PHASE4

A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee

NCT06828666

Osteoarthritis of Knee

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Augmented Microdrilling Surgery

Group Type EXPERIMENTAL

Microdrilling Surgery

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No