Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy
NCT ID: NCT00613535
Last Updated: 2015-05-19
Study Results
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Basic Information
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TERMINATED
PHASE4
165 participants
INTERVENTIONAL
2008-04-30
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lavage debridement to remove loose fragments
Articular cartilage defect left untreated by surgical tool during partial meniscectomy
Lavage debridement
Remove loose chondral fragments
Mechanical Debridement
Remove large chondral flaps and loose fragments
Mechanical debridement
Mechanical shaver will be used to remove large chondral flaps and loose fragments
Mechanical Debridement
Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
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
Paragon T2
Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
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.
Interventions
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Mechanical debridement
Mechanical shaver will be used to remove large chondral flaps and loose fragments
Paragon T2
Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
Lavage debridement
Remove loose chondral fragments
Mechanical Debridement
Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle
Exclusion Criteria
* 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)
* 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
18 Years
60 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frank A Pettrone, M.D.
Role: PRINCIPAL_INVESTIGATOR
Commonwealth Orthopaedics
Locations
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HOPE Research Institute
Phoenix, Arizona, United States
Kerlan Jobe Orthopaedic Foundation
Los Angeles, California, United States
JDP Medical Research
Aurora, Colorado, United States
Colorado Orthopedic Consultants, P.C.
Englewood, Colorado, United States
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, United States
University of Mass. Memorial Medical Center
Worcester, Massachusetts, United States
University of Rochester Medical Center Department of Musculoskeletal Research
Rochester, New York, United States
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States
Commonwealth Orthopaedics
Arlington, Virginia, United States
Anderson Clinic
Arlington, Virginia, United States
Countries
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References
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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. doi: 10.1016/j.arthro.2006.11.015.
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. doi: 10.1053/jars.2002.32839.
Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. doi: 10.1016/j.knee.2007.02.001. 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. doi: 10.1053/jars.2002.31783.
Brittberg M, Winalski CS. Evaluation of cartilage injuries and repair. J Bone Joint Surg Am. 2003;85-A Suppl 2:58-69. doi: 10.2106/00004623-200300002-00008. 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. doi: 10.2106/00004623-200300002-00002.
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. doi: 10.1177/0363546504273510.
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. doi: 10.3109/17453679608994664.
Fowler P. Arthroscopic lavage or debridement did not reduce pain more than placebo did in patients with osteoarthritis. J Bone Joint Surg Am. 2003 Feb;85(2):387. doi: 10.2106/00004623-200302000-00038. 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. doi: 10.1053/jars.2002.29906.
Barber FA, Iwasko NG. Treatment of grade III femoral chondral lesions: mechanical chondroplasty versus monopolar radiofrequency probe. Arthroscopy. 2006 Dec;22(12):1312-7. doi: 10.1016/j.arthro.2006.06.008.
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. doi: 10.2106/JBJS.D.02846.
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. doi: 10.1302/0301-620x.85b7.13782.
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. doi: 10.1177/0363546507304328. 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. doi: 10.1016/s0278-5919(02)00015-7.
Other Identifiers
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1093528
Identifier Type: -
Identifier Source: secondary_id
A-706-DHH
Identifier Type: -
Identifier Source: org_study_id
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