Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions

Christopher Kaeding6 enrolled

Overview

The purpose of this study is to evaluate the changes in clinical and imaging outcomes following arthroscopic treatment of chondral lesion(s) by Radiofrequency-Based debridement or Mechanical Debridement in subjects 18-50 years of age.

This is a non-inferiority, prospective, single blinded, randomized, single-center study design with enrollment of 82 randomized subjects (to assure 70 subjects complete the study). The sample size of 82 participants was calculated from a power analysis. The study was powered to detect at least a seven point change in KOOS pain score based on achieving 80% statistical power to detect a non-inferiority margin. Study duration will be until the last subject enrolled reaches 52 weeks post-operative. The 82 randomized subjects will be randomized at a 1:1 ratio into the Werewolf Coblation wand treatment group or mechanical debridement treatment group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent arthroscopy, the blinded assignment will be revealed to the subject.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Articular Cartilage Disorder of Knee

Interventions

Radiofrequency-Based DebridementDEVICE

In this process, radiofrequency energy is used to excite the water molecules in a conductive medium, such as an electrolyte (saline) solution, to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds (16-18), excising or dissolving (i.e. ablating) soft tissue at relatively low temperatures (typically 40ºC to 70ºC).

Mechanical DebridementDEVICE

Arthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Given written informed consent on the IRB approved consent form specific to the study, prior to study participation * 18-50 years old * Male or Female * Suspected chondral damage in the following locations where debridement is indicated: * Medial femoral condyle * Lateral femoral condyle * Trochlea * Patella * \< 30% joint space narrowing as seen on x-ray (merchant view, AP and PA Rosenberg) * 1 or more chondral lesion(s) as noted on MRI Exclusion Criteria: * Previous chondral treatment in the same compartment (prior debridement and lavage performed more than three months prior to baseline are acceptable) * Focal chondral defect indicated for concomitant procedures (i.e., microfracture, ACI, MACI, OATs) * Concomitant procedures that are not allowed: * Lateral retinacular release * Excision of osteophytes * Subchondroplasty * Manipulation under anesthesia * ACL reconstruction * Quad tendon repair * Patellar tendon repair * Patellar tendon debridement * Multiligament reconstruction * Pregnant and/or intending to become pregnant during this study period

Locations (1)

The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale

The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.