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Tidal Lavage in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00000424
First received: November 3, 1999
Last updated: December 28, 2006
Last verified: March 2001

November 3, 1999
December 28, 2006
July 1995
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Complete list of historical versions of study NCT00000424 on ClinicalTrials.gov Archive Site
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Tidal Lavage in Knee Osteoarthritis
Tidal Lavage vs. Sham Lavage in Knee Osteoarthritis (OA)

This study compared the effects of tidal lavage (washing out) of the knee joint and an imitation lavage procedure in people with knee osteoarthritis. In tidal lavage, the doctor flushes out a knee joint with repeated injections of a mild salt solution, done under local anesthesia. Study participants had to meet standard criteria for diagnosis of osteoarthritis but could have low, medium, or high severity of x-ray changes indicating knee osteoarthritis. We performed the lavage procedure once, and did quarterly followups for 1 year. We permitted patients to use some other osteoarthritis treatments during the study, such as non-narcotic pain relievers, nonsteroidal anti-inflammatory drugs, and physical therapy.

This study was a randomized, double-blind, sham procedure-controlled evaluation of tidal lavage as a treatment for knee osteoarthritis. We achieved blinding by raising a drape during the study procedure and mimicking the sensory aspects of tidal lavage, but not flushing the knee, in the sham lavage group. We gave all study participants subcutaneous anesthesia with lidocaine and then bupivacaine and then attempted aspiration of the knee, removing up to 5 ml of synovial fluid for examination and then injecting the knee with 20 ml of bupivicaine.

In people who received the sham treatment, we placed a 16-gauge catheter in the lateral suprapatellar position just to the knee joint capsule and infused small volumes (less than 5 ml per "exchange" x 20) of saline into the subcutaneous tissue while manipulating the anterior knee to mimic efforts to shift fluid within the knee during the "aspiration" phase of each exchange. Patients could see the supply bag of sterile saline but could not see the waste bag of this closed drainage system.

For tidal lavage patients, we made the catheter puncture in the lateral suprapatellar pouch and repeatedly distended the knee with 30-50 ml of sterile saline, then aspirated this volume (about 20 exchanges for a total of 1 liter of flush solution).

At the end of the procedure, we told the patients that their knee might be swollen due to retained saline, and to expect this additional swelling to resolve over 24-48 hours, during which time they were to minimize activity. The person who did the procedure (the principal investigator) then left the room. The study nurse, who was not present for the procedure and was blinded to the procedure's identity, asked the patients which treatment they thought they received (tidal lavage or sham lavage). We scheduled patient followups with this study nurse for 3, 6, and 12 months, and patients completed questionnaires at each visit. Questionnaires were both arthritis-specific (WOMAC) and global (Quality of Well-Being).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis, Knee
Procedure: Tidal lavage vs. sham lavage of the knee
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
June 2001
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Inclusion Criteria:

  • Knee pain attributed to osteoarthritis for at least 1 year.
  • Meet American College of Rheumatology clinical or clinical plus x-ray criteria for knee osteoarthritis
  • Have at least a moderate pain rating on at least one of the five Western Ontario-McMaster University Osteoarthritis Index (WOMAC) scales

Exclusion Criteria:

  • Significant conditions of the spine, hips, or feet that affect the ability to walk
  • Significant medical conditions that affect the ability to walk and function
  • Inflammatory arthritis, such as rheumatoid arthritis or gout
  • Degenerative arthritis secondary to other conditions, such as hemochromatosis, Wilson's disease, or ochronosis
  • Current significant soft tissue rheumatism such as fibromyalgia, anserine bursitis, or trochanteric bursitis
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000424
R01 AR42165, NIAMS-001
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: John D. Bradley, MD Indiana University School of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
March 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP