Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy - Full Text View

Sponsor:	ArthroCare Corporation
Information provided by:	ArthroCare Corporation
ClinicalTrials.gov Identifier:	NCT00613535

Purpose

The purpose of this post-marketing surveillance study is to determine the proportion of study participants who demonstrate tissue stability, as seen using magnetic resonance imaging (MRI), at the site of partial thickness articular cartilage defect on the femoral condyle observed during arthroscopy 6 months earlier and treated using one of three standard clinical methods.

Condition	Intervention	Phase
Partial Meniscectomy Articular Cartilage Defect	Device: Mechanical Shaver Device: Paragon T2	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Tissue Concomitant With Partial Meniscectomy

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans

U.S. FDA Resources

Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:

In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion [ Time Frame: 6 months after arthroscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	145
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lavage or washing of the knee joint with saline solution: No Intervention Articular cartilage defect left untreated by surgical tool during partial meniscectomy
Mechanical Shaver: Active Comparator	Device: Mechanical Shaver Mechanical shaver will be used to remove large chondral flaps and loose fragments
RF based chondroplasty: Active Comparator	Device: Paragon T2 Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.

Detailed Description:

Fibrillated articular cartilage are commonly detected during arthroscopy when treating knee pathologies such as a torn meniscus or a damaged anterior cruciate ligament (ACL). The severity of these lesions is graded using a scheme such as the International Cartilage Research Society (ICRS) classification system. Grade I lesions are often left untreated, while Grade IV lesions require dedicated surgical intervention. Grade II and III lesions are frequently treated when they are encountered arthroscopically.

Currently, it is not known whether treatment of fibrillated articular cartilage is beneficial or whether one procedure is superior to another. Magnetic resonance imaging is the best technique currently available for non-invasive assessment of chondral lesions. The primary aim of the proposed study is to compare post-procedure MR imaging characteristics of fibrillated articular cartilage treated using one of the three standard of care measures: 1) Washing of the knee joint with saline solution to clear blood, fluid or loose tissue (also known as lavage); 2) Lavage in addition to mechanical shaver (a manual surgical tool used by the study doctor); and 3)Lavage in addition to the Paragon device (RF-based microdebridement), which may also be used with a mechanical (or manual) surgical tool. The secondary aim is to determine the association between imaging features and clinical outcomes.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:Screening

Age between 18 and 60 years
BMI <35
Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging
Minimal abnormality of opposite knee as shown by clinical exam and/or imaging
Candidate for unilateral arthroscopic treatment of the knee
Visual Analog Scale (VAS) score of 3 or greater in the knee to be treated (index knee)
Physically and mentally willing and able to comply with study requirements
Must be willing and able to follow the standardized rehabilitation protocol (Appendix C)
Subject must sign IRB approved informed consent form

Arthroscopy Inclusion Criteria:

Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the femoral condyle

Exclusion Criteria: Screening

Knee instability, malalignment, or patella tracking dysfunction
Joint space narrowing as seen by AP xray
Varus (>10 degrees) or Valgus (>15 degrees) knee deformities as seen by AP xray
Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis
Previous total meniscectomy
Previous surgical treatment of index knee by arthroscopy within 2 years of enrollment into the study
Previous knee tendon and/or ligament repair or patellar surgery of index knee
Previous microfracture or bone marrow stimulation of the index knee
Previous unsuccessful osteotomy
Presence of avascular necrosis
Presence of fractures, osteocysts or osteolysis
Participation in another clinical study
Terminally ill
Drug therapy for the index knee with systemic steroid therapy, steroid intra- articular therapy or intra-articular hyaluronic acid therapy within 6 months of enrollment into this study
Receiving pain medication for other condition unrelated to knee injury
Contralateral knee involvement causing abnormal ambulation and non-compliance with rehabilitation
Pregnant or suspected pregnant

Arthroscopy Exclusion Criteria:

Grade IV chondromalacia
ACL tear on the index knee
Osteochondritis dissecans (OCD)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613535

Contacts

Contact: Deborah A. Tominack	703-863-5007	trialsva@erols.com
Contact: Wendy Winters, BS	408-735-6278	wwinters@arthrocare.com

Locations

United States, California
Kerlan Jobe Orthopaedic Foundation	Recruiting
Los Angeles, California, United States, 90045
Contact: Karen Mohr, P.T. 310-665-7129 karenmohr@aol.com
Principal Investigator: Ralph Gambardella, MD
United States, Massachusetts
University of Mass. Memorial Medical Center	Recruiting
Worcester, Massachusetts, United States, 01685
Contact: Dawn Bombard, RN, CCRC 774-443-7865 bombardd@ummhc.org
Principal Investigator: Brian Busconi, MD
United States, New York
University of Rochester Medical Center Department of Musculoskeletal Research	Recruiting
Rochester, New York, United States, 14642
Contact: Sara Defendorf 585-341-9305 Sara_Defendorf@URMC.Rochester.edu
Principal Investigator: Ilya Voloshin, MD
United States, Virginia
Commonwealth Orthopaedics	Recruiting
Arlington, Virginia, United States, 22205
Contact: Deborah Tominack, RN (703)528-0385 trialsva@erols.com
Sub-Investigator: Christopher Annunziata, MD
Sub-Investigator: Gordon Lee Avery, MD
Sub-Investigator: John Patrick McConnell, MD
Principal Investigator: Frank Pettrone, MD

Sponsors and Collaborators

ArthroCare Corporation

Investigators

Principal Investigator:

Frank A. Pettrone, M.D.

Commonwealth Orthopaedics

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Figueroa D, Calvo R, Vaisman A, Carrasco MA, Moraga C, Delgado I. Knee chondral lesions: incidence and correlation between arthroscopic and magnetic resonance findings. Arthroscopy. 2007 Mar;23(3):312-5.

Hjelle K, Solheim E, Strand T, Muri R, Brittberg M. Articular cartilage defects in 1,000 knee arthroscopies. Arthroscopy. 2002 Sep;18(7):730-4.

Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. Epub 2007 Apr 10.

Sgaglione NA, Miniaci A, Gillogly SD, Carter TR. Update on advanced surgical techniques in the treatment of traumatic focal articular cartilage lesions in the knee. Arthroscopy. 2002 Feb;18(2 Suppl 1):9-32.

Brittberg M, Winalski CS. Evaluation of cartilage injuries and repair. J Bone Joint Surg Am. 2003;85-A Suppl 2:58-69. No abstract available.

Shelbourne KD, Jari S, Gray T. Outcome of untreated traumatic articular cartilage defects of the knee: a natural history study. J Bone Joint Surg Am. 2003;85-A Suppl 2:8-16.

Alford JW, Cole BJ. Cartilage restoration, part 1: basic science, historical perspective, patient evaluation, and treatment options. Am J Sports Med. 2005 Feb;33(2):295-306. Review.

Messner K, Maletius W. The long-term prognosis for severe damage to weight-bearing cartilage in the knee: a 14-year clinical and radiographic follow-up in 28 young athletes. Acta Orthop Scand. 1996 Apr;67(2):165-8.

Fowler P. Arthroscopic lavage or débridement did not reduce pain more than placebo did in patients with osteoarthritis. J Bone Joint Surg Am. 2003 Feb;85-A(2):387. No abstract available.

Owens BD, Stickles BJ, Balikian P, Busconi BD. Prospective analysis of radiofrequency versus mechanical debridement of isolated patellar chondral lesions. Arthroscopy. 2002 Feb;18(2):151-5.

Barber FA, Iwasko NG. Treatment of grade III femoral chondral lesions: mechanical chondroplasty versus monopolar radiofrequency probe. Arthroscopy. 2006 Dec;22(12):1312-7.

Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20.

Henderson IJ, Tuy B, Connell D, Oakes B, Hettwer WH. Prospective clinical study of autologous chondrocyte implantation and correlation with MRI at three and 12 months. J Bone Joint Surg Br. 2003 Sep;85(7):1060-6.

Voloshin I, Morse KR, Allred CD, Bissell SA, Maloney MD, DeHaven KE. Arthroscopic evaluation of radiofrequency chondroplasty of the knee. Am J Sports Med. 2007 Oct;35(10):1702-7. Epub 2007 Jul 20.

Yetkinler DN, Greenleaf JE, Sherman OH. Histologic analysis of radiofrequency energy chondroplasty. Clin Sports Med. 2002 Oct;21(4):649-61, viii. Review.

Responsible Party:	ArthroCare Corporation ( Wendy Winters )
Study ID Numbers:	A-706-DHH, 1093528
Study First Received:	January 31, 2008
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00613535 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by ArthroCare Corporation:

Articular Cartilage Defect
Partial Meniscectomy
Partial Thickness Knee Tear
MR Imaging
Mechanical Shaver
Crepitus
Stability
Coblation
Bipolar Radiofrequency

Debridement
Recurrent Knee Pain
meniscectomy
partial meniscectomy
meniscus
cartilage lesion
articular cartilage lesion
articular cartilage
knee

ClinicalTrials.gov processed this record on November 27, 2009