Distal Radius FractureEarly Phase 1NCT02318433
Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
A Early Phase 1 study testing Dexamethasone and Saline in people with Distal Radius Fracture and Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture, Osteoarthritis
- What is being tested?
- Dexamethasone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 19 Jul 2019
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unstable distal radius fracture
- Fracture type AO B1, B2, B3, C1, C2 or C3.
- 18-65 years old
- Understand and read English
- Community dwelling (not in assisted living or NH)
Who cannot join
- Open or bilateral DRF
- Associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of DRF fixation.
- Greater than 2 weeks post injury
- Neurologic disorders affecting the hand, wrist or arm.
- History of permanent dementia, Alzheimer's or other neurologic dx
- Substance abuse
Show all 9Show fewer
- Pathologic fractures
- Known pregnancy
- Radiocarpal joint arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis.
Read the detailed description
Our hypothesis is that the intra-articular administration of dexamethasone soon after joint injury will prevent the subsequent development of PTOA, and restore normal joint homeostasis. We plan to generate the data needed to test this hypothesis in a Phase 0 (pilot) clinical trial using patients who have suffered distal radius fractures.
- Conditions
- Distal Radius Fracture, Osteoarthritis
- Being tested
- Dexamethasone, Saline
- Keywords
- DRF, PTOA, dexamethasone
- Medical subject headings
- Wrist Fractures, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR. Receives: Drug: Dexamethasone |
| Saline | Placebo comparator | Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTOA incidence
Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.
Measured: 3 years
Secondary outcomes (2)
Functional assessment
A composite of clinical measurements of grip strength and pinch strength.
Measured: 3 years
Patient-rated evaluations
Composite scores from patient-rated evaluations including the Disabilities of the Arm Shoulder and Hand (DASH), the Michigan Hand Questionnaire (MHQ), and the Patient-Rated Wrist Evaluation (PRWE).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjeev (Sanj) Kakar, M.D., M.B.A., Mayo Clinic
- Investigators
- Sanjeev Kakar, M.D., M.B.A, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318433
- Sponsor's protocol ID
- 14-004033
- Status last verified
- Mar 2020
- First submitted
- 8 Dec 2014
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT02318433
- Acronym / sponsor ID
- 14-004033
- Conditions
- Distal Radius Fracture, Osteoarthritis
- Keywords
- DRF, PTOA, dexamethasone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 17 Dec 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 primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis.
Detailed description
Our hypothesis is that the intra-articular administration of dexamethasone soon after joint injury will prevent the subsequent development of PTOA, and restore normal joint homeostasis. We plan to generate the data needed to test this hypothesis in a Phase 0 (pilot) clinical trial using patients who have suffered distal radius fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneSubjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR. |
| Saline | Placebo comparator | Drug: SalineSubjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unstable distal radius fracture
- Fracture type AO B1, B2, B3, C1, C2 or C3.
- 18-65 years old
- Understand and read English
- Community dwelling (not in assisted living or NH)
Key exclusion criteria (9 listed)
- Open or bilateral DRF
- Associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of DRF fixation.
- Greater than 2 weeks post injury
- Neurologic disorders affecting the hand, wrist or arm.
- History of permanent dementia, Alzheimer's or other neurologic dx
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 |
|---|---|---|
| DexamethasoneData demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression. | Drug | Dexamethasone |
| Saline | Drug | Saline |
Primary outcome
PTOA incidence
Time frame: 3 years
Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.
2 secondary outcomes
Functional assessment
Time frame: 3 years
Patient-rated evaluations
Time frame: 3 years
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 13 Apr 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Sanjeev Kakar, M.D., M.B.A principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone and Saline in people with Distal Radius Fracture and Osteoarthritis, run by Mayo Clinic 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 5 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 13 Apr 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
PTOA incidence (time frame: 3 years). 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 13 Apr 2020.