Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Mid Cheshire Hospitals NHS Foundation Trust.
Recruitment status was Not yet recruiting
Information provided by:
Mid Cheshire Hospitals NHS Foundation Trust
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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.
Procedure: extensor tendon repair
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- DASH score [ Time Frame: 3, 6, 12 and 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Range of movement at distal interphalyngeal joint. [ Time Frame: 3, 6, 12 and 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- soft tissue mallet finger
- acute injury
- ASA 3 or above
- Unable to give informed consent
- Infection in digit affected
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No publications provided
||Mr Philip Holland, Mersey Deanery
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 18, 2009
||November 18, 2009
||United Kingdom: Research Ethics Committee
Keywords provided by Mid Cheshire Hospitals NHS Foundation Trust:
ClinicalTrials.gov processed this record on March 25, 2015
Soft tissue mallet finger