ReNu™ Injection to Treat Hip Osteoarthritis Study

NCT ID: NCT03063099

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2019-06-28

Brief Summary

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

Detailed Description

This is a prospective, non-randomized pilot study evaluating the efficacy of ReNu™ hip injection on patients with moderate osteoarthritis. The effects will be measured primarily through patient-reported outcomes questionnaires after a single injection. Patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.

Conditions

Osteoarthritis, Hip

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ReNu™ Injection

ReNu™ is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.

Group Type: EXPERIMENTAL

ReNu™ Injection

Intervention Type: OTHER

Injection into the hip for the treatment of Osteoarthritis.

Interventions

ReNu™ Injection

Injection into the hip for the treatment of Osteoarthritis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organogenesis

INDUSTRY

Sponsor Role: collaborator

NuTech Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katie Mowry, PhD

Role: STUDY_DIRECTOR

Organogenesis

Locations

Stanford Medicine Orthopaedic Surgery

Redwood City, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

RD2016-01-01

Identifier Type: -

Identifier Source: org_study_id