Finger InjuryNCT01016197
Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial
A study testing extensor tendon repair and Mallet splint for 4 weeks in people with Finger Injury, run by Mid Cheshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators are investigating if surgical treatment of injuries to the tendon which straightens the finger tip gives a better functional outcome than treatment with a splint while the tendon heals. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Finger Injury
- What is being tested?
- extensor tendon repair and Mallet splint for 4 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Jun 2011
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- soft tissue mallet finger
- acute injury
Who cannot join
- ASA 3 or above
- Unable to give informed consent
- Infection in digit affected
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are investigating if surgical treatment of injuries to the tendon which straightens the finger tip gives a better functional outcome than treatment with a splint while the tendon heals.
Read the detailed description
The investigators will randomise patients to receive splinting of their finger while their tendon heals or have surgical intervention. Surgical intervention will entail fixing the tendon with bone anchors and splinting. Conservative treament involves splinting while the tendon heals. We will then monitor the functional outcome of the hand using the DASH questionare over 18 months.
- Conditions
- Finger Injury
- Being tested
- extensor tendon repair, Mallet splint for 4 weeks
- Keywords
- Soft tissue mallet finger
- Medical subject headings
- Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extensor tendon repairProcedure or surgery
Surgical repair of extensor tendon with bone anchor and splinting
Mallet splint for 4 weeksProcedure or surgery
The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Active comparator | Four weeks of splinting followed by mobilisation. Receives: Procedure: Mallet splint for 4 weeks |
| Surgery | Experimental | Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation. Receives: Procedure: extensor tendon repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH score
Measured: up to 18 months
Secondary outcomes (1)
Range of movement at distal interphalyngeal joint.
Measured: 3, 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finger InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid Cheshire Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Investigators
- Philip Holland, MBChB, MRCS, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016197
- Sponsor's protocol ID
- PH1
- Status last verified
- Sep 2016
- First submitted
- 18 Nov 2009
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01016197
- Acronym / sponsor ID
- PH1
- Conditions
- Finger Injury
- Keywords
- Soft tissue mallet finger
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mid Cheshire Hospitals NHS Foundation TrustOther government
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Nov 2009 (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 investigators are investigating if surgical treatment of injuries to the tendon which straightens the finger tip gives a better functional outcome than treatment with a splint while the tendon heals.
Detailed description
The investigators will randomise patients to receive splinting of their finger while their tendon heals or have surgical intervention. Surgical intervention will entail fixing the tendon with bone anchors and splinting. Conservative treament involves splinting while the tendon heals. We will then monitor the functional outcome of the hand using the DASH questionare over 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | Active comparator | Procedure: Mallet splint for 4 weeksFour weeks of splinting followed by mobilisation. |
| Surgery | Experimental | Procedure: extensor tendon repairSurgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- soft tissue mallet finger
- acute injury
Key exclusion criteria (3 listed)
- ASA 3 or above
- Unable to give informed consent
- Infection in digit affected
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 |
|---|---|---|
| extensor tendon repairSurgical repair of extensor tendon with bone anchor and splinting | Procedure or surgery | Surgery |
| Mallet splint for 4 weeksThe patient will wear a "mallet splint" for fours weeks and then mobilise their finger. | Procedure or surgery | Conservative |
Primary outcome
DASH score
Time frame: up to 18 months
1 secondary outcome
Range of movement at distal interphalyngeal joint.
Time frame: 3, 6, 12 and 18 months
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 27 Sep 2016.
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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.
Philip Holland, MBChB, MRCS principal investigator
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extensor tendon repair and Mallet splint for 4 weeks in people with Finger Injury, run by Mid Cheshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 2 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: withdrawn, as of the sponsor's last update on 27 Sep 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 Kingdom. 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 score (time frame: up to 18 months). 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 27 Sep 2016.