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

Sponsor:	ArthroCare Corporation
Information provided by (Responsible Party):	ArthroCare Corporation
ClinicalTrials.gov Identifier:	NCT00613535

Purpose

The aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based debridement.

Condition	Intervention	Phase
Torn Meniscus Articular Cartilage Defect	Device: Mechanical debridement Device: Paragon T2 Procedure: Lavage debridement Device: Mechanical Debridement Device: RF- based Debridement	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Lesions 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:	165
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lavage debridement to remove loose fragments Articular cartilage defect left untreated by surgical tool during partial meniscectomy	Procedure: Lavage debridement Remove loose chondral fragments
Active Comparator: Mechanical Debridement Remove large chondral flaps and loose fragments	Device: Mechanical debridement Mechanical shaver will be used to remove large chondral flaps and loose fragments Device: Mechanical Debridement Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
Active Comparator: RF based Debridement Debridement to remove loose fragments followed by use of Paragon T-2 RF wand to smooth the base of the shoulder of the tear	Device: Paragon T2 Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver. Device: RF- based Debridement Use of debridement device to remove large fragments followed by use of RF-based debridement to smooth the base of the shoulder of the tear.

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:	No

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 in the index knee
No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee
No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization
No Varus (>10 degrees) or Valgus (>15 degrees)knee deformities as seen by AP X-ray in the index knee
Minimal or no abnormality of contralateral knee as shown by clinical exam and/or imaging
Candidate for unilateral arthroscopic treatment of the knee
Visual Analog Scale (VAS) pain score of 30 mm or greater in the index knee at the time of screening
Must be able to undergo MRI at required time points per appendix D
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 medial or lateral femoral condyle

Exclusion Criteria: Screening

Knee instability, malalignment, or patellar tracking dysfunction in the index knee
Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee
Previous total meniscectomy in the index knee
Previous surgical treatment of the index knee by arthroscopy less than 2 years prior to treatment by this study
Previous total meniscectomy
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 in the index knee
Presence of fractures, osteocysts or osteolysis in the index knee
Presence of osteoarthritis in the index knee
Pre-existent osteoarthritis of weight-bearing joints (e.g. hips or contralateral knee) that adversely affects gait
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 2 months of enrollment into this study
Receiving narcotic pain medication by prescription for other conditions unrelated to knee injury
Contralateral knee involvement causing abnormal ambulation and non-compliance with rehabilitation
Pregnant or suspected pregnant
Coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery)

Arthroscopy Exclusion Criteria:

Presence of Grade IV chondromalacia anywhere in the index knee
ACL, PCL or MCL tear of the index knee
Osteochondritis dissecans (OCD)of the index knee
Meniscal tear requiring total meniscectomy
Evidence of osteoarthritis in the index knee

Contacts and Locations

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

Contacts

Contact: Pam Aakhus, BSN	408-735-6719	Pamela.Aakhus@ArthroCare.com
Contact: Heather Neill, BSN	512-358-5764	Heather.Neill@ArthroCare.com

Locations

United States, Arizona
HOPE Research Institute	Recruiting
Phoenix, Arizona, United States, 85050
Contact: Calvin Truong, M.D. 602-288-4673 Calvin.Truong@trialtrack.com
Principal Investigator: Jon D. Zoltan, M.D.
United States, California
Kerlan Jobe Orthopaedic Foundation	Active, not recruiting
Los Angeles, California, United States, 90045
United States, Colorado
JDP Medical Research	Recruiting
Aurora, Colorado, United States, 80014
Contact: Julie M Knight, CMA 303-260-9650 jknight@jdpmedicalresearch.com
Contact: Eve Casiano 303-671-0933 ecasiano@jdpmedicalresearch.com
Principal Investigator: John D. Papilion, M.D.
Colorado Orthopedic Consultants, P.C.	Recruiting
Englewood, Colorado, United States, 80110
Contact: Krystal Payton 303-695-6060 ext 258 KPayton@cocortho.com
Principal Investigator: Philip A. Stull, M.D.
United States, Florida
Shrock Orthopedic Research, LLC	Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Wendy Schwartz, MPH 954-764-8033 ext 309 Wendy@shrockresearch.com
Contact: Natalie Shrock, NP 954-764-8033 Natalie@shrockresearch.com
Principal Investigator: Kevin Shrock, M.D.
United States, Massachusetts
University of Mass. Memorial Medical Center	Recruiting
Worcester, Massachusetts, United States, 01685
Contact: Renee Merolli, RN, MA 508-334-6077 Renee.Merolli2@umassmemorial.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, Texas
Basin Orthopedic Surgical Specialists	Recruiting
Odessa, Texas, United States, 79761
Contact: Deborah Mossbarger, RN 432-332-2663 bossresearch@hotmail.com
Principal Investigator: Steven C. Riley, M.D.
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
Anderson Clinic	Active, not recruiting
Arlington, Virginia, United States, 22206

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
ClinicalTrials.gov Identifier:	NCT00613535 History of Changes
Other Study ID Numbers:	A-706-DHH, 1093528
Study First Received:	January 31, 2008
Last Updated:	October 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by ArthroCare Corporation:

Articular Cartilage Defect
Partial Meniscectomy
Partial Thickness Knee Tear
MR Imaging
Mechanical Debridement
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 February 12, 2012