Osteoarthritis, HipNCT03063099
ReNu™ Injection to Treat Hip Osteoarthritis Study
A study testing ReNu™ Injection in people with Osteoarthritis, Hip, run by NuTech Medical, Inc at 2 sites in United States.
Trial summary
A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis receiving the ReNu™ Hip Injection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- ReNu™ Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Feb 2017to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Stanford Medicine Orthopaedic Surgery
Redwood City, California, 94063
About this study
Official title: A Pilot Study of ReNu™ Hip Injection: Monitoring the Response of Hip Function and Pain in Patient With Osteoarthritis
A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis receiving the ReNu™ Hip Injection.
Read the detailed 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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- ReNu™ Injection
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReNu™ InjectionOther
Injection into the hip for the treatment of Osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| ReNu™ Injection | Experimental | ReNu™ is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. Receives: Other: ReNu™ Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
IHOT12 - International Hip Outcome Tool 12
Change from Baseline
Measured: 3 & 6 months
Visual Analog Scale (VAS) Pain Scale
Change from Baseline
Measured: 3 & 6 months
Secondary outcomes (3)
Modified Harris Hip Score
Change from Baseline
Measured: 3, 6 & 12 months
SF12 Score
Generic measure of patient's health status change from baseline
Measured: 3, 6 & 12 months
Single Assessment Numerical Evaluation (SANE)
Measurement tool used to record patient's self-reported change in function from baseline
Measured: 3, 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start8 Feb 2017
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuTech Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Responsible party
- Sponsor
- Investigators
- Katie Mowry, PhD, Study director, Organogenesis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063099
- Sponsor's protocol ID
- RD2016-01-01
- Status last verified
- Jan 2020
- First submitted
- 21 Feb 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of ReNu™ Hip Injection: Monitoring the Response of Hip Function and Pain in Patient With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03063099
- Acronym / sponsor ID
- RD2016-01-01
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis receiving the ReNu™ Hip Injection.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReNu™ Injection | Experimental | Other: ReNu™ InjectionReNu™ is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReNu™ InjectionInjection into the hip for the treatment of Osteoarthritis. | Other | ReNu™ Injection |
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
3 secondary outcomes
Modified Harris Hip Score
Time frame: 3, 6 & 12 months
SF12 Score
Time frame: 3, 6 & 12 months
Single Assessment Numerical Evaluation (SANE)
Time frame: 3, 6 & 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Mowry, PhD study director
Organogenesis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReNu™ Injection in people with Osteoarthritis, Hip, run by NuTech Medical, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IHOT12 - International Hip Outcome Tool 12 (time frame: 3 & 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.