Clinical Trial: ReNu™ Injection to Treat Hip Osteoarthritis Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: NuTech Medical, Inc

Current Primary Outcome:

• IHOT12 - International Hip Outcome Tool 12 [ Time Frame: 3 & 6 months ]
  Change from Baseline
• Visual Analog Scale (VAS) Pain Scale [ Time Frame: 3 & 6 months ]
  Change from Baseline

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Modified Harris Hip Score [ Time Frame: 3, 6 & 12 months ]
  Change from Baseline
• SF12 Score [ Time Frame: 3, 6 & 12 months ]
  Generic measure of patient's health status change from baseline
• 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

Original Secondary Outcome:

• Modified Harris Hip Score [ Time Frame: 3, 6 & 12 months ]
  Change from Baseline
• SF12 Score [ Time Frame: 3, 6 & 12 months ]
  Change from Baseline
• Single Assessment Numerical Evaluation (SANE) [ Time Frame: 3, 6 & 12 months ]
  Change from Baseline

Information By: NuTech Medical, Inc

Dates:
Date Received: February 21, 2017
Date Started: February 8, 2017
Date Completion: December 2018
Last Updated: May 15, 2017
Last Verified: May 2017