Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid

StimLabs

Status

Terminated

Conditions

Knee Osteoarthritis

Treatments

Procedure: Ascent

Procedure: Standard

Study type

Interventional

Funder types

Industry

Identifiers

NCT03710005

SLAC-ORTHO-001

Details and patient eligibility

About

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

Full description

To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent

Enrollment

51 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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