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Trial record 1 of 1 for:    NCT02318511
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An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02318511
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Organogenesis
Information provided by (Responsible Party):
NuTech Medical, Inc

Tracking Information
First Submitted Date  ICMJE December 9, 2014
First Posted Date  ICMJE December 17, 2014
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE June 2015
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • VAS Pain Scale Change from Baseline [ Time Frame: 3 months ]
  • VAS Pain Scale Change from Baseline [ Time Frame: 6 months ]
  • KOOS Pain and Function Subscales Change from Baseline [ Time Frame: 3 months ]
  • KOOS Pain and Function Subscales Change from Baseline [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • KOOS Pain and Function Subscales change from Baseline [ Time Frame: 1 week, 6 weeks, 3 months, and 12 months ]
  • Other patient reported outcomes (PROs) change from Baseline [ Time Frame: 1 week, 6 week, 3 months, 6 months, and 12 months ]
  • Radiographic (X-ray) measurement of standing joint space change from Baseline [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis
Official Title  ICMJE An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients With Osteoarthritis
Brief Summary This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA) injection - with commonly used injection material and 3) Saline. After treatment, patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Procedure: Knee injection
    Injection into knee for the treatment of Osteoarthritis
  • Other: ReNu amniotic allograft
  • Device: placebo saline
  • Device: Hyaluronic Acid
Study Arms  ICMJE
  • Experimental: ReNu amniotic allograft
    Knee injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
    Interventions:
    • Procedure: Knee injection
    • Other: ReNu amniotic allograft
  • Placebo Comparator: Saline
    Knee injection with saline. Injectable saline will be used as the placebo control.
    Interventions:
    • Procedure: Knee injection
    • Device: placebo saline
  • Active Comparator: HA injection
    Knee injection with HA. HA will be used as a viscosupplementation injection consisting of cross linked HA.
    Interventions:
    • Procedure: Knee injection
    • Device: Hyaluronic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2016)
200
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2014)
150
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with moderate knee osteoarthritis determined by a combination of clinical and radiographic findings and documented by Kellgren-Lawrence radiographic classification (Grade 2 or 3)
  • Grade 2 Kellgren-Lawrence radiographic changes are defined as small osteophytes, possible narrowing of joint space
  • Grade 3 Kellgren-Lawrence radiographic changes are defined as moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour.
  • Patients with bilateral grade 2 or 3 Kellgren Lawrence knee osteoarthritis who have bilateral symptoms may have their more symptomatic knee injected. If equivalent symptoms are reported by the patient, then the patient will choose which knee is to be injected. The contralateral knee can be treated with local standard of care such as steroid injection, cold therapy or soft brace.
  • Age 18 and older
  • BMI less than 40
  • 7 day average pain score of 4 or greater for the involved knee on a numeric pain scale from 1 to 10.
  • Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal

Exclusion Criteria:

  • Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15 days before injection (may take acetaminophen)
  • Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index knee
  • 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 knee 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
  • Positive pregnancy test on premenopausal subject
  • Morbid obesity (defined as BMI 40 or greater)
  • Symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body
  • Corticosteroid injection into the index knee within 3 months
  • Viscosupplement injection into the index knee within 3 months
  • Knee surgery of involved index knee within 12 months
  • Knee surgery contralateral knee 6 months
  • Worker compensation
  • Acute index knee 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02318511
Other Study ID Numbers  ICMJE RD2014-10-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NuTech Medical, Inc
Study Sponsor  ICMJE NuTech Medical, Inc
Collaborators  ICMJE Organogenesis
Investigators  ICMJE
Principal Investigator: Jack Farr, MD OrthoIndy
PRS Account NuTech Medical, Inc
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP