Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy

NCT00613535 | Terminated Phase 4

• 2 other identifiers: A-706-DHH1093528
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Torn Meniscus

Keywords

Partial Meniscectomy; Partial Thickness Knee Tear; MR Imaging; Mechanical Debridement; Crepitus; Stability; Coblation; Bipolar Radiofrequency; Debridement; Recurrent Knee Pain; meniscectomy; meniscus; cartilage lesion; articular cartilage lesion; articular cartilage; knee

Outcome Measures

Primary Outcomes (1)

• In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion

  6 months after arthroscopy

Secondary Outcomes (1)

• To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups

  Up to 24 months

Study Arms (3)

Lavage debridement to remove loose fragments

ACTIVE COMPARATOR

Articular cartilage defect left untreated by surgical tool during partial meniscectomy

Procedure: Lavage debridement

Mechanical Debridement

ACTIVE COMPARATOR

Remove large chondral flaps and loose fragments

Device: Mechanical debridement

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

Device: Paragon T2; Device: RF- based Debridement

Interventions

Mechanical Debridement DEVICE

Mechanical shaver will be used to remove large chondral flaps and loose fragments

Mechanical Debridement

Paragon T2 DEVICE

Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.

RF based Debridement

Lavage debridement PROCEDURE

Remove loose chondral fragments

Lavage debridement to remove 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.

RF based Debridement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (10)

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Kerlan Jobe Orthopaedic Foundation

Los Angeles, California, 90045, United States

Location

JDP Medical Research

Aurora, Colorado, 80014, United States

Location

Colorado Orthopedic Consultants, P.C.

Englewood, Colorado, 80110, United States

Location

Shrock Orthopedic Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

University of Mass. Memorial Medical Center

Worcester, Massachusetts, 01685, United States

Location

University of Rochester Medical Center Department of Musculoskeletal Research

Rochester, New York, 14642, United States

Location

Basin Orthopedic Surgical Specialists

Odessa, Texas, 79761, United States

Location

Commonwealth Orthopaedics

Arlington, Virginia, 22205, United States

Location

Anderson Clinic

Arlington, Virginia, 22206, United States

Location

Related Publications (15)

• 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.

  PMID: 17349476 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.

  PMID: 12209430 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.

  PMID: 17428666 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.

  PMID: 11828343 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.

  PMID: 12721346 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.

  PMID: 12721340 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.

  PMID: 15701618 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.

  PMID: 8623573 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.

  PMID: 12571328 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.

  PMID: 11830808 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.

  PMID: 17157730 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.

  PMID: 16140804 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.

  PMID: 14516048 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.

  PMID: 17644661 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.

  PMID: 12489295 BACKGROUND

Study Officials

• Frank A Pettrone, M.D.

  Commonwealth Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

US (10)