NCT03063099

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

February 21, 2017

Last Update Submit

January 13, 2020

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (2)

  • IHOT12 - International Hip Outcome Tool 12

    Change from Baseline

    3 & 6 months

  • Visual Analog Scale (VAS) Pain Scale

    Change from Baseline

    3 & 6 months

Secondary Outcomes (3)

  • Modified Harris Hip Score

    3, 6 & 12 months

  • SF12 Score

    3, 6 & 12 months

  • Single Assessment Numerical Evaluation (SANE)

    3, 6 & 12 months

Study Arms (1)

ReNu™ Injection

EXPERIMENTAL

ReNu™ is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.

Other: ReNu™ Injection

Interventions

ReNu™ InjectionOTHER

Injection into the hip for the treatment of Osteoarthritis.

ReNu™ Injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Medicine Orthopaedic Surgery

Redwood City, California, 94063, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Katie Mowry, PhD

    Organogenesis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

February 24, 2017

Study Start

February 8, 2017

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)