Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid

Stopped early · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.

Key facts

Study ID

NCT03710005

Run by

StimLabs

People needed

51

Starts

2018-10-22

Expected to finish

2021-05-31

Last updated by the study team

2024-07-01

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 20 years but less than 75 years old
• Both male and female (non-pregnant)
• Valid knee radiograph within 3 months of beginning treatment;
• Diagnosis of OA of the knee
• OA pain in the knee despite conservative measures
• Average daily VAS >= 3
• Off any NSAIDs for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection
• Kellgren-Lawrence system of Grade II, III, or IV

You may not qualify if…

• Kellgren-Lawrence Grade I
• Tense effusion of the knee
• Significant valgus/varus deformities
• Viscosupplementation within 6 months
• Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening
• Chronic opioid usage
• History of Leukemia or Lymphoma
• History of any autoimmune disorders and disease
• Immunosuppressive medications
• Active, suspected, or prior infection to the joint
• Vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...)
• NSAIDs used within 1 week of the procedure
• History of bleeding disorders or inflammatory joint disease
• Patients who plan on becoming pregnant during study period

Where it is running

• Emory Sports Medicine Complex — Brookhaven, Georgia, United States
• Emory At Dunwoody — Dunwoody, Georgia, United States
• Emory Orthopaedics and Spine Center — Johns Creek, Georgia, United States
• Emory at Smyrna — Smyrna, Georgia, United States

Full record on ClinicalTrials.gov

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