Humeral FracturesPhase 2NCT04216017
Glenohumeral Cortisone Injection
A Phase 2 study testing kenalog and Lidocaine in people with Humeral Fractures, run by University of Washington at 1 site in United States.
Trial summary
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- kenalog and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18-90
- 2. Proximal Humerus Fracture
- 3. Decreased range of motion at 6 wk follow-up
- 4. Likely to be available for follow up for 26 wks
Who cannot join
- Known drug allergy to kenalog or lidocaine
- Unable to complete functional outcome
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
Read the detailed description
THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
- Conditions
- Humeral Fractures
- Being tested
- kenalog, Lidocaine
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kenalogDrug
Cortisone injection into shoulder
LidocaineDrug
Lidocaine injection into shoulder
| Study group | Role | What they receive |
|---|---|---|
| Controls | Placebo comparator | Patients receiving lidocaine Receives: Drug: Lidocaine |
| Cases | Active comparator | Patients receiving Kenalog Receives: Drug: kenalog |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder Elbow Society Score
Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Measured: 24 weeks
Secondary outcomes (1)
Visual Analogue Scale
pain scale - high is bad - low is good 0-100
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Humeral FracturesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Jonah Hebert-Davies, University of Washington
- Investigators
- Jonah Hebert-Davies, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216017
- Sponsor's protocol ID
- STUDY00007576
- Other IDs
- P30AR072572
- Status last verified
- Aug 2023
- First submitted
- 24 Dec 2019
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT04216017
- Acronym / sponsor ID
- STUDY00007576
- Conditions
- Humeral Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Posted 26 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
Detailed description
THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | Placebo comparator | Drug: LidocainePatients receiving lidocaine |
| Cases | Active comparator | Drug: kenalogPatients receiving Kenalog |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.18-90
- 2. Proximal Humerus Fracture
- 3. Decreased range of motion at 6 wk follow-up
- 4. Likely to be available for follow up for 26 wks
Key exclusion criteria (3 listed)
- Known drug allergy to kenalog or lidocaine
- Unable to complete functional outcome
- Pregnant Women
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 |
|---|---|---|
| kenalogCortisone injection into shoulder | Drug | Cases |
| LidocaineLidocaine injection into shoulder | Drug | Controls |
Primary outcome
American Shoulder Elbow Society Score
Time frame: 24 weeks
Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
1 secondary outcome
Visual Analogue Scale
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Comparison of Functional Outcomes Between Triceps Tongue Elevation vs Olecranon Osteotomy in Intra Articular Distal Humerus Fracture (IA-DH) Management
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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.
Jonah Hebert-Davies, MD principal investigator
University of Washington
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 kenalog and Lidocaine in people with Humeral Fractures, run by University of Washington 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 4 inclusion and 3 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 26 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
American Shoulder Elbow Society Score (time frame: 24 weeks). 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 26 Sep 2023.