Hip Pain Etiology UnknownPhase 2NCT02066844
Navigator vs Standard Needle Injection for Hip
A Phase 2 study testing Celestone and Lidocaine in people with Hip Pain Etiology Unknown, run by Cartiva, Inc. at 1 site in United States.
Trial summary
The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Pain Etiology Unknown
- What is being tested?
- Celestone and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ≥18 years of age, of any race or ethnicity;
- Capable of completing self-administered questionnaires;
- Patients with suspected intra-articular hip pain who have failed conservative care (conservative care defined as a standard regimen of home or outpatient physical therapy, activity modification, trial of at least one NSAID) for at least 3 months;
- Candidate for a hip injection;
- Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Institutional Review Board/Ethics Committee.
- Subjects are able to understand and speak English
Who cannot join
- History of intra-articular injection within the last 3 months prior to the injection procedure;
- Complex regional pain syndrome;
- History of prior hip surgery;
- History of substance abuse;
- Known history of hypersensitivity to local anesthetics of the amide type;
- Contraindicated for Celestone (betamethasone sodium phosphate);
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- Contraindicated for Lidocaine Hydrochloride;
- Is a prisoner or ward of the state;
- Are unable to meet the treatment and follow up protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Navigator vs Standard Needle Injection for Hip
The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.
- Conditions
- Hip Pain Etiology Unknown
- Being tested
- Celestone, Lidocaine
- Keywords
- Hip Pain, Hip Injection, Hip Fracture, Hip Bursitis, Hip Arthritis, Hip Sciatica
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelestoneDrug
Also called Betamethasone Sodium Phosphate
2cc
LidocaineDrug
5cc
| Study group | Role | What they receive |
|---|---|---|
| Standard Manual Needle Injection | Active comparator | 2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon Receives: Drug: Celestone; Drug: Lidocaine |
| Navigator Injection | Experimental | 2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon Receives: Drug: Celestone; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection Pain as measured by VAS for both treatment groups
Measured: From 1 week to 12 weeks post-injection
Secondary outcomes (3)
Global Patient Satisfaction
Measured: From 1 week to 12 weeks post-injection
Drug Preparation Time
Measured: From 1 week to 12 weeks post-injection
Hip Pain and Function
Measured: From 1 week to 12 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain Etiology UnknownStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Giordano, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066844
- Sponsor's protocol ID
- PTC-0369
- Status last verified
- Jan 2016
- First submitted
- 17 Feb 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Navigator vs Standard Needle Injection for Hip
- ClinicalTrials.gov ID
- NCT02066844
- Acronym / sponsor ID
- PTC-0369
- Conditions
- Hip Pain Etiology Unknown
- Keywords
- Hip Pain, Hip Injection, Hip Fracture, Hip Bursitis, Hip Arthritis, Hip Sciatica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cartiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Feb 2014 (estimated)
- 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.
The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Manual Needle Injection | Active comparator | Drug: Celestone, Drug: Lidocaine2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon |
| Navigator Injection | Experimental | Drug: Celestone, Drug: Lidocaine2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females, ≥18 years of age, of any race or ethnicity;
- Capable of completing self-administered questionnaires;
- Patients with suspected intra-articular hip pain who have failed conservative care (conservative care defined as a standard regimen of home or outpatient physical therapy, activity modification, trial of at least one NSAID) for at least 3 months;
- Candidate for a hip injection;
- Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Institutional Review Board/Ethics Committee.
Key exclusion criteria (9 listed)
- History of intra-articular injection within the last 3 months prior to the injection procedure;
- Complex regional pain syndrome;
- History of prior hip surgery;
- History of substance abuse;
- Known history of hypersensitivity to local anesthetics of the amide type;
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 |
|---|---|---|
| CelestoneAlso: Betamethasone Sodium Phosphate2cc | Drug | Navigator Injection, Standard Manual Needle Injection |
| Lidocaine5cc | Drug | Navigator Injection, Standard Manual Needle Injection |
Primary outcome
Injection Pain as measured by VAS for both treatment groups
Time frame: From 1 week to 12 weeks post-injection
3 secondary outcomes
Global Patient Satisfaction
Time frame: From 1 week to 12 weeks post-injection
Drug Preparation Time
Time frame: From 1 week to 12 weeks post-injection
Hip Pain and Function
Time frame: From 1 week to 12 weeks post-injection
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 28 Jan 2016.
- Individual participant dataSharing planned: No
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.
Brian Giordano, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celestone and Lidocaine in people with Hip Pain Etiology Unknown, run by Cartiva, Inc. at 1 site 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 6 inclusion and 9 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Injection Pain as measured by VAS for both treatment groups (time frame: From 1 week to 12 weeks post-injection). 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 28 Jan 2016; AzTrials last refreshed its copy on 28 Oct 2026.