ReNu™ Injection to Treat Hip Osteoarthritis Study

Completed · Not applicable

Conditions studied: Osteoarthritis, Hip

In brief

A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis receiving the ReNu™ Hip Injection.

Key facts

Study ID

NCT03063099

Run by

NuTech Medical, Inc

People needed

10

Starts

2017-02-08

Expected to finish

2019-06-28

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with moderate hip osteoarthritis determined by a combination of clinical and radiographic findings
• Radiographic findings consistent with osteoarthritis as documented by Tonnis radiographic classification (Grade 1 or 2)
• Grade 1 Tonnis changes are defined as mild and include increased sclerosis, slight narrowing of the joint space, no or slight loss of head sphericity
• Grade 2 Tonnis changes are defined as moderate and include small cysts, moderate narrowing of the joint space, moderate loss of head sphericity
• Patients with bilateral grade 1or 2 Tonnis hip osteoarthritis who have bilateral symptoms may have their more symptomatic hip injected. If equivalent symptoms are reported by the patient, then the patient will choose which hip is to be injected. The other Hip can be treated with all standard local interventions that will not have a prolonged systemic effect that could affect the study hip (for example steroid injection, cold therapy, soft braces).
• Between the Ages 18 to 70 with minimum activity level of 2 on the Tegner scale.
• BMI less than 40
• Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal

You may not qualify if…

• Pain medication (including NSAIDs) less than 15 days before injection (may take acetaminophen)
• Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index hip
• Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of antiplatelet medications are not a reason for exclusion
• History of substance abuse.
• Failure to agree NOT to take additional hip symptom modifying drugs, other than acetaminophen, during the course of the study without reporting to the study team
• Pregnancy or desire to become pregnant during study duration
• Corticosteroid injection into the index hip within 6 months
• Viscosupplement injection into the index hip within 6 months
• Previous open or arthroscopic hip surgery of the involved index hip within the previous 6 months
• Open or arthroscopic surgery of the contralateral hip within the last 6 months
• Worker compensation
• Acute index hip injury (injury within 3 months)
• History of Diabetes mellitus
• History of solid organ or hematologic transplantation
• History of rheumatoid arthritis or other autoimmune disorder
• Diagnosis of a non-basal cell malignancy within the preceding 5 years
• Infection requiring antibiotic treatment within the preceding 3 months
• Current therapy with any immunosuppressive medication, including corticosteroids at a dose > 5 mg per day

Where it is running

• Stanford Medicine Orthopaedic Surgery — Redwood City, California, United States
• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.