Injury Distal to Flexor and Extensor Tendon InsertionsNCT00580164
The Role of Splinting in Fingertip Injuries
An observational study of Injury Distal to Flexor and Extensor Tendon Insertions, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is attempting to understand whether or not splinting after a fingertip injury improves recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury Distal to Flexor and Extensor Tendon Insertions
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2010
- Phase
- Observational
- 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
Study population: Orthopaedic Hand Clinic
Who may be able to join
- injury distal to flexor and extensor tendon insertions
- crush, avulsion, amputation, or penetrating injury to the fingertip
- isolated injury, within two weeks
Who cannot join
- operative fixation required
- unable to participate in rehab
Trial locations and contacts
1 site in 1 country.
About this study
This study is attempting to understand whether or not splinting after a fingertip injury improves recovery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Splint | |
| 2 | No Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH questionnaire, Grip strength, and Range of Motion
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionMay 2010
- Study completionDec 2010
Why it stopped: Very few subjects were enrolled. Therefore, 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 Injury Distal to Flexor and Extensor Tendon InsertionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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 C Ring, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580164
- Sponsor's protocol ID
- 2006-p000239
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2007
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Splinting in Fingertip Injuries
- ClinicalTrials.gov ID
- NCT00580164
- Acronym / sponsor ID
- 2006-p000239
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Very few subjects were enrolled. Therefore, the study was terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Dec 2007 (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.
This study is attempting to understand whether or not splinting after a fingertip injury improves recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Splint |
| 2 | – | –No Splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopaedic Hand Clinic
Key inclusion criteria (3 listed)
- injury distal to flexor and extensor tendon insertions
- crush, avulsion, amputation, or penetrating injury to the fingertip
- isolated injury, within two weeks
Key exclusion criteria (2 listed)
- operative fixation required
- unable to participate in rehab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DASH questionnaire, Grip strength, and Range of Motion
Time frame: 1 month
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 30 Dec 2015.
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 C Ring, MD 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?
An observational study of Injury Distal to Flexor and Extensor Tendon Insertions, 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 3 inclusion and 2 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 30 Dec 2015. 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?
DASH questionnaire, Grip strength, and Range of Motion (time frame: 1 month). 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 30 Dec 2015.