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| ID | Type | Description | Link |
|---|---|---|---|
| 1093528 |
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The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p<0.05).
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavage debridement to remove loose fragments | Active Comparator | Articular cartilage defect left untreated by surgical tool during partial meniscectomy |
|
| Mechanical Debridement | Active Comparator | Remove large chondral flaps and loose fragments |
|
| RF based Debridement | Active Comparator | Debridement to remove loose fragments followed by use of Paragon T-2 RF wand to smooth the base of the shoulder of the tear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical debridement | Device | Mechanical shaver will be used to remove large chondral flaps and loose fragments |
|
| Measure | Description | Time Frame |
|---|---|---|
| In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion | 6 months after arthroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups | Up to 24 months |
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Inclusion Criteria:Screening
Arthroscopy Inclusion Criteria:
Exclusion Criteria: Screening
Arthroscopy Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank A Pettrone, M.D. | Commonwealth Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States | ||
| Kerlan Jobe Orthopaedic Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17349476 | Background | 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. | |
| 12209430 | Background | 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. |
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| Paragon T2 | Device | Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver. |
|
| Lavage debridement | Procedure | Remove loose chondral fragments |
|
| Mechanical Debridement | Device | Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments |
|
| RF- based Debridement | Device | 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. |
|
| Los Angeles |
| California |
| 90045 |
| United States |
| JDP Medical Research | Aurora | Colorado | 80014 | United States |
| Colorado Orthopedic Consultants, P.C. | Englewood | Colorado | 80110 | United States |
| Shrock Orthopedic Research, LLC | Fort Lauderdale | Florida | 33316 | United States |
| University of Mass. Memorial Medical Center | Worcester | Massachusetts | 01685 | United States |
| University of Rochester Medical Center Department of Musculoskeletal Research | Rochester | New York | 14642 | United States |
| Basin Orthopedic Surgical Specialists | Odessa | Texas | 79761 | United States |
| Commonwealth Orthopaedics | Arlington | Virginia | 22205 | United States |
| Anderson Clinic | Arlington | Virginia | 22206 | United States |
| 17428666 | Background | 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. |
| 11828343 | Background | 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. |
| 12721346 | Background | 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. |
| 12721340 | Background | 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. |
| 15701618 | Background | 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. |
| 8623573 | Background | 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. |
| 12571328 | Background | 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. |
| 11830808 | Background | 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. |
| 17157730 | Background | 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. |
| 16140804 | Background | 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. |
| 14516048 | Background | 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. |
| 17644661 | Background | 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. |
| 12489295 | Background | 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. |