Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000424
Status:
COMPLETED
Last Update Posted:
2007-01-01
First Post:
1999-11-03
Brief Title:
Tidal Lavage in Knee Osteoarthritis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Tidal Lavage vs Sham Lavage in Knee Osteoarthritis OA
Status:
COMPLETED
Status Verified Date:
2001-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 procedures 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
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 procedures 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-001 | None | None | None |