ReNu™ Injection to Treat Hip Osteoarthritis Study

A Pilot Study of ReNu™ Hip Injection: Monitoring the Response of Hip Function and Pain in Patient With Osteoarthritis

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Other: ReNu™ 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Medicine Orthopaedic Surgery
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ReNu™ Injection; ReNu™ is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.	Other: ReNu™ Injection; Injection into the hip for the treatment of Osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IHOT12 - International Hip Outcome Tool 12	Change from Baseline	3 & 6 months
Visual Analog Scale (VAS) Pain Scale	Change from Baseline	3 & 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Harris Hip Score	Change from Baseline	3, 6 & 12 months
SF12 Score	Generic measure of patient's health status change from baseline	3, 6 & 12 months
Single Assessment Numerical Evaluation (SANE)	Measurement tool used to record patient's self-reported change in function from baseline	3, 6 & 12 months

Collaborators and Investigators

• Sponsor: NuTech Medical, Inc
• Collaborators: Organogenesis
• Investigators: Study Director: Katie Mowry, PhD, Organogenesis

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2017
• Primary Completion (ACTUAL): June 28, 2019
• Study Completion (ACTUAL): June 28, 2019

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: RD2016-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No