Patients Present With Mallet FingerNCT02210676
Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger
A study testing PROMIS Upper Extremity, Likert Pain Scale and Mallet Finger Extensor Lag Measurement in people with Patients Present With Mallet Finger, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Aim: The purpose of the study is to learn more about how a person recovers after treatment for mallet finger injury. The investigators want to identify the best outcome after mallet finger injury and how to improve treatment strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Present With Mallet Finger
- What is being tested?
- PROMIS Upper Extremity, Likert Pain Scale and Mallet Finger Extensor Lag Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jan 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- English fluency and literacy
- Mallet finger fracture or non-fracture
- Mallet finger subluxation or non-subluxation
Who cannot join
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Aim:
The purpose of the study is to learn more about how a person recovers after treatment for mallet finger injury. The investigators want to identify the best outcome after mallet finger injury and how to improve treatment strategies.
Read more
Primary null hypothesis:
There are no statistically significant factors associated with extensor lag between 4 weeks and 4 months after immobilization is discontinued for a mallet finger among demographic, injury, and treatment factors.
Secondary null hypothesis:
There are no statistically significant factors associated with PROMIS upper extremity function between 4 weeks and 4 months after completion of immobilization for a mallet finger among demographic, psychological, injury, and treatment factors.
- Conditions
- Patients Present With Mallet Finger
- Being tested
- PROMIS Upper Extremity, Likert Pain Scale, Mallet Finger Extensor Lag Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS Upper ExtremityOther
Likert Pain ScaleOther
Mallet Finger Extensor Lag MeasurementOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with Mallet Finger | Experimental | All enrolled patients Receives: Other: PROMIS Upper Extremity; Other: Likert Pain Scale; Other: Mallet Finger Extensor Lag Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mallet Finger Extensor Lag
Measured: Baseline
Mallet Finger Extensor Lag
Measured: 4 weeks to 4 months after diagnosis
Secondary outcomes (3)
Patient Reported Outcomes Measure Information System (PROMIS) Upper Extremity
A computerized assessment of upper extremity function
Measured: 4 weeks to 4 months after diagnosis
Likert Pain Scale
Measured: 4 weeks to 4 months after diagnosis
Demographics Questionnaire
Measured: 4 weeks to 4 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2016
Why it stopped: Due to the investigator leaving the institution, the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Present With Mallet FingerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210676
- Sponsor's protocol ID
- 2014P001041
- Status last verified
- Dec 2016
- First submitted
- 5 Aug 2014
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger
- ClinicalTrials.gov ID
- NCT02210676
- Acronym / sponsor ID
- 2014P001041
- Conditions
- Patients Present With Mallet Finger
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the investigator leaving the institution, the study was terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (actual)
- First posted
- 7 Aug 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.
Aim:
The purpose of the study is to learn more about how a person recovers after treatment for mallet finger injury. The investigators want to identify the best outcome after mallet finger injury and how to improve treatment strategies.
Primary null hypothesis:
There are no statistically significant factors associated with extensor lag between 4 weeks and 4 months after immobilization is discontinued for a mallet finger among demographic, injury, and treatment factors.
Secondary null hypothesis:
There are no statistically significant factors associated with PROMIS upper extremity function between 4 weeks and 4 months after completion of immobilization for a mallet finger among demographic, psychological, injury, and treatment factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Mallet Finger | Experimental | Other: PROMIS Upper Extremity, Other: Likert Pain Scale, Other: Mallet Finger Extensor Lag MeasurementAll enrolled patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older
- English fluency and literacy
- Mallet finger fracture or non-fracture
- Mallet finger subluxation or non-subluxation
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| PROMIS Upper Extremity | Other | Patients with Mallet Finger |
| Likert Pain Scale | Other | Patients with Mallet Finger |
| Mallet Finger Extensor Lag Measurement | Other | Patients with Mallet Finger |
Primary outcome
Mallet Finger Extensor Lag
Time frame: Baseline
Mallet Finger Extensor Lag
Time frame: 4 weeks to 4 months after diagnosis
3 secondary outcomes
Patient Reported Outcomes Measure Information System (PROMIS) Upper Extremity
Time frame: 4 weeks to 4 months after diagnosis
Likert Pain Scale
Time frame: 4 weeks to 4 months after diagnosis
Demographics Questionnaire
Time frame: 4 weeks to 4 months after diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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.
David Ring, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMIS Upper Extremity, Likert Pain Scale and Mallet Finger Extensor Lag Measurement in people with Patients Present With Mallet Finger, run by Massachusetts General Hospital 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 1 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: withdrawn, as of the sponsor's last update on 22 Dec 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mallet Finger Extensor Lag (time frame: Baseline). 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 22 Dec 2016; AzTrials last refreshed its copy on 1 Nov 2026.