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ReNu™ Injection to Treat Hip Osteoarthritis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03063099
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Organogenesis
Information provided by (Responsible Party):
NuTech Medical, Inc

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Other: ReNu™ Injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of ReNu™ Hip Injection: Monitoring the Response of Hip Function and Pain in Patient With Osteoarthritis
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  1. IHOT12 - International Hip Outcome Tool 12 [ Time Frame: 3 & 6 months ]
    Change from Baseline

  2. Visual Analog Scale (VAS) Pain Scale [ Time Frame: 3 & 6 months ]
    Change from Baseline


Secondary Outcome Measures :
  1. Modified Harris Hip Score [ Time Frame: 3, 6 & 12 months ]
    Change from Baseline

  2. SF12 Score [ Time Frame: 3, 6 & 12 months ]
    Generic measure of patient's health status change from baseline

  3. Single Assessment Numerical Evaluation (SANE) [ Time Frame: 3, 6 & 12 months ]
    Measurement tool used to record patient's self-reported change in function from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063099


Locations
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United States, California
Stanford Medicine Orthopaedic Surgery
Redwood City, California, United States, 94063
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
NuTech Medical, Inc
Organogenesis
Investigators
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Study Director: Katie Mowry, PhD Organogenesis
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Responsible Party: NuTech Medical, Inc
ClinicalTrials.gov Identifier: NCT03063099    
Other Study ID Numbers: RD2016-01-01
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases