Osteoarthritis, KneePhase 2NCT00000424
Tidal Lavage in Knee Osteoarthritis
A Phase 2 study of Osteoarthritis, Knee, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1995to Jun 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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 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).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Tidal lavage vs. sham lavage of the knee
- Keywords
- Osteoarthritis (OA), Knee, Sham lavage, Tidal lavage, Lavage therapy, Nonsteroidal anti-inflammatory drug (NSAID), Placebo, Radiography, Human therapy evaluation, WOMAC
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal lavage vs. sham lavage of the kneeProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1995
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- John D. Bradley, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000424
- Sponsor's protocol ID
- R01AR042165
- Other IDs
- NIAMS-001
- Status last verified
- Mar 2001
- First submitted
- 3 Nov 1999
- Last updated
- 1 Jan 2007
- Results posted
- No
Publications
Bradley JD, Heilman DK, Wallick JE, Olin P. Effect of blinding on response to tidal lavage (TL) and sham lavage (SL) in knee osteoarthritis (KOA). Arthritis Rheum 42(Supplement):S292,1999.
Bradley JD, Heilman DK, G'Sell P: Do psychological factors "predict" response to tidal lavage (TL) and sham lavage (SL) in knee osteoarthritis (KOA)? Arthritis Rheum 43(Supplement):S337,2000
Bradley JD. Joint irrigation as treatment for osteoarthritis. Curr Rheumatol Rep. 2003 Feb;5(1):20-6. doi: 10.1007/s11926-003-0079-4.
PubMed 12590881Bradley JD, Heilman DK, Katz BP, Gsell P, Wallick JE, Brandt KD. Tidal irrigation as treatment for knee osteoarthritis: a sham-controlled, randomized, double-blinded evaluation. Arthritis Rheum. 2002 Jan;46(1):100-8. doi: 10.1002/1529-0131(200201)46:13.0.co;2-v.
PubMed 11817581
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tidal Lavage vs. Sham Lavage in Knee Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT00000424
- Acronym / sponsor ID
- R01AR042165
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis (OA), Knee, Sham lavage, Tidal lavage, Lavage therapy, Nonsteroidal anti-inflammatory drug (NSAID), Placebo, Radiography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Jul 1995
- Study completion
- Jun 2001
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tidal lavage vs. sham lavage of the knee | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2007.
- BackgroundBradley JD, Heilman DK, Wallick JE, Olin P. Effect of blinding on response to tidal lavage (TL) and sham lavage (SL) in knee osteoarthritis (KOA). Arthritis Rheum 42(Supplement):S292,1999.
- BackgroundBradley JD, Heilman DK, G'Sell P: Do psychological factors "predict" response to tidal lavage (TL) and sham lavage (SL) in knee osteoarthritis (KOA)? Arthritis Rheum 43(Supplement):S337,2000
- Background: PubMed 12590881Bradley JD. Joint irrigation as treatment for osteoarthritis. Curr Rheumatol Rep. 2003 Feb;5(1):20-6. doi: 10.1007/s11926-003-0079-4.
- Results publication: PubMed 11817581Bradley JD, Heilman DK, Katz BP, Gsell P, Wallick JE, Brandt KD. Tidal irrigation as treatment for knee osteoarthritis: a sham-controlled, randomized, double-blinded evaluation. Arthritis Rheum. 2002 Jan;46(1):100-8. doi: 10.1002/1529-0131(200201)46:13.0.co;2-v.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Bradley, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Osteoarthritis, Knee, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000424, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2007.