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

NCT01803880 | Terminated Results DMC

• 1 other identifier: SM-2012-02
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.

Conditions

Chondral Lesion Plus Partial Medial Meniscectomy

Keywords

Articular cartilage; Cartilage lesion; Cartilage defect; Radiofrequency; Debridement; Cartilage; Coblation; Knee; Meniscus; Meniscectomy; MR imaging; Mechanical debridement; Mechanical shaver; Torn meniscus; Arthroscopic knee surgery; Damaged cartilage

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative

  The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living \[ADL\], Function in Sport and Recreation \[Sport/Rec\] and knee related Quality of Life \[QoL\]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method). Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems. KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)

  Postop Week 52

Secondary Outcomes (13)

• Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.

  Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET)

• Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation

  Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET

• Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation

  Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET

• Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation

  Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET

• Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation

  Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET

Study Arms (2)

Mechanical Debridement

ACTIVE COMPARATOR

Mechanical shaver removes areas of damaged tissue

Device: Mechanical Debridement

RF-based Debridement

ACTIVE COMPARATOR

Electrical energy removes areas of damaged tissue (Coblation®)

Device: RF-Based Debridement

Interventions

Mechanical Debridement DEVICE

mechanical shaver that removes areas of damaged tissue

Also known as: Mechanical Shaver

Mechanical Debridement

RF-Based Debridement DEVICE

Electrical energy that removes areas of damaged tissue (Coblation®)

Also known as: Paragon T2 ICW, FLOW 50 wand

RF-based Debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects MUST meet ALL of the following criteria to be included in the study:
• Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
• Is male or non pregnant female ≥ eighteen (18) years of age
• MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator)
• Must present with pain in the index knee of moderate or severe (\> 30 mm) as measured by the VAS
• Must be able to understand English (written and oral)
• Must be available to come to all study related visits and is physically and mentally willing and able to comply with all post-operative evaluations
• Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
• Subjects MUST meet ALL of the following criteria to be included in the study:
• \. Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters:
• Single, treatable chondral lesion, localized to the medial femoral condyle,
• ICRS Grade 2 with widely displaceable fibrillation or flaps or Grade 3A,
• \< 4cm2 in size

You may not qualify if:

• Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
• Body Mass Index (BMI) \> 40 or index joint pain is due to BMI (as determined by Investigator)
• Requires bilateral knee surgery
• Any of the following conditions:
• active joint infections
• is immunocompromised, has Sickle Cell disease, has a primary bone disease (e.g., Paget's disease) or disorders that may adversely affect the healing process, or is terminally ill
• inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout)
• metastatic and/or neoplastic disease
• infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)
• coagulation disorder or patient is receiving anti-coagulants
• documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within 12 months of enrollment into this study
• diagnosed with a behavioral condition which could affect their ability to accurately comply with the study (e.g. developmental delay, attention deficit disorder, and autism)
• Any of the following conditions in the index limb or joint:
• Grade III or greater osteoarthritis as determined by AP radiograph (Kellgren-Lawrence classification)
• systemic steroid therapy or steroid intra-articular therapy within 4 weeks of enrollment into this study

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Andrews Research and Education Foundation, Inc.

Gulf Breeze, Florida, 32561, United States

Location

Orthopaedic Research Foundation, Inc.

Greenwood, Indiana, 46143, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Methodist Center For Orthopedic Surgery

Houston, Texas, 77070, United States

Location

Basin Orthopedic Surgical Specialists

Odessa, Texas, 79761, United States

Location

Limitations and Caveats

Due to early termination of the study, all inferential analyses were noted as descriptive and the clinical outcome results should be interpreted with caution.

Results Point of Contact

• Title: Stephan Mangin, Director, Global Clinical Strategy
• Organization: Smith & Nephew, Inc

stephan.mangin@smith-nephew.com

M +1 (512) 913-8192

Study Officials

• Jack Farr II, MD

  Orthopaedic Research Foundation, Inc.

  PRINCIPAL INVESTIGATOR

• Beate Hansen, MD, PhD

  Vice President, Global Clinical Strategy

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: March 4, 2013
• Study Start: March 8, 2013
• Primary Completion: May 4, 2017
• Study Completion: July 21, 2017
• Last Updated: March 28, 2019
• Results First Posted: March 28, 2019

Record last verified: 2019-03

Locations

US (7)