An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

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

Tracking Information

• First Submitted Date: December 9, 2014
• First Posted Date: December 17, 2014
• Last Update Posted Date: January 18, 2020
• Study Start Date: June 2015
• Actual Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Osteoarthritis

Intervention

• Procedure: Knee injection
  Injection into knee for the treatment of Osteoarthritis
• Other: ReNu amniotic allograft
• Device: placebo saline
• Device: Hyaluronic Acid

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2016): 200
• Original Estimated Enrollment (submitted: December 16, 2014): 150
• Actual Study Completion Date: February 2019
• Actual Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02318511
• Other Study ID Numbers: RD2014-10-04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: NuTech Medical, Inc
• Study Sponsor: NuTech Medical, Inc
• Collaborators: Organogenesis

Investigators

• Principal Investigator: Jack Farr, MD; OrthoIndy

• PRS Account: NuTech Medical, Inc
• Verification Date: January 2020