Completed

Tidal Lavage vs. Sham Lavage for Knee Osteoarthritis Treatment

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What is being tested

Data Collection

Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

Over 40 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 1995
See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1995

Actual date on which the first participant was enrolled.

This study focuses on knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The main goal is to evaluate the effectiveness of a treatment called 'tidal lavage' compared to a 'sham lavage'. Tidal lavage involves cleaning out the knee joint with a saline solution. This research is important because it could potentially provide a new treatment option for people suffering from knee osteoarthritis, improving their quality of life. During the study, participants receive local anesthesia to numb the knee area. Those in the tidal lavage group have a catheter inserted into their knee, through which saline solution is repeatedly injected and then removed. This process is intended to clean out the knee joint. On the other hand, participants in the sham lavage group have a catheter placed near the knee, but the saline solution is not injected into the joint itself, only into the surrounding tissue. This is done to mimic the sensation of tidal lavage without actually performing the procedure. After the procedure, participants are asked about their perceived treatment and are followed up at 3, 6, and 12 months to assess their condition using arthritis-specific and global well-being questionnaires.

Official TitleTidal Lavage vs. Sham Lavage in Knee Osteoarthritis (OA)
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

3 inclusion criteria required to participate
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

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Indiana University School of Medicine

Indianapolis, United StatesOpen Indiana University School of Medicine in Google Maps
CompletedOne Study Center