ReNu™ Injection to Treat Hip Osteoarthritis Study

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063099
• Other study ID #: RD2016-01-01
• Status: Completed
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: June 28, 2019

Study information

• Verified date: January 2020
• Source: NuTech Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• ReNu™ Injection
Injection into the hip for the treatment of Osteoarthritis.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Stanford Medicine Orthopaedic Surgery	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
NuTech Medical, Inc	Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IHOT12 - International Hip Outcome Tool 12	Change from Baseline	3 & 6 months
Primary	Visual Analog Scale (VAS) Pain Scale	Change from Baseline	3 & 6 months
Secondary	Modified Harris Hip Score	Change from Baseline	3, 6 & 12 months
Secondary	SF12 Score	Generic measure of patient's health status change from baseline	3, 6 & 12 months
Secondary	Single Assessment Numerical Evaluation (SANE)	Measurement tool used to record patient's self-reported change in function from baseline	3, 6 & 12 months