Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Lidocaine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. The patient must be between the ages of 18 and 80

2. Informed consent has been obtained from the patient

3. The patient must have diagnosed symptomatic osteoarthritis of the tibio-femoral or patello-femoral compartment of the target knee for at least 1 month

4. The patient has moderate-to-severe knee pain reflected by an average visual analogue scale (VAS) score of 4 or greater (out of a possible 10) over the previous 7 days.

5. Radiographic imaging must show grade II-III osteoarthritis on the Kellgren & Lawrence Scale.

6. Patients may have bilateral osteoarthritis but only patients with unilateral symptoms may be included.

Exclusion Criteria:

1. Knee instability

2. A score less than 4 (out of a possible 10) on their intake VAS

3. Major axial deviation (>5º valgus or varus deviation as evidenced on a standard of care x-ray.

4. Previous surgery at the target knee < 6 months.

5. Symptomatic osteoarthritis of the contralateral knee or any other joint.

6. Systemic or intra articular injection to any joint with corticosteroids within 6 months prior to screening

7. Previous joint injection of any type in the past 6 months

8. Systemic conditions that could interfere with outcome such as Rheumatoid arthritis, coagulopathy, and anemia.

9. Allergy to any of the injected substances.

10. Any patient unable to cease NSAID usage (other than low dose aspirin) due to unrelated condition.

11. Cognitive impairment or unable to provide informed consent

12. Recent knee trauma with violation of the intra-articular bone.