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Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016197
First Posted: November 19, 2009
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mid Cheshire Hospitals NHS Foundation Trust
November 18, 2009
November 19, 2009
September 27, 2016
January 2010
January 2011   (Final data collection date for primary outcome measure)
DASH score [ Time Frame: up to 18 months ]
DASH score [ Time Frame: 3, 6, 12 and 18 months ]
Complete list of historical versions of study NCT01016197 on ClinicalTrials.gov Archive Site
Range of movement at distal interphalyngeal joint. [ Time Frame: 3, 6, 12 and 18 months ]
Same as current
Not Provided
Not Provided
 
Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial
Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Finger Injury
  • Procedure: extensor tendon repair
    Surgical repair of extensor tendon with bone anchor and splinting
  • Procedure: Mallet splint for 4 weeks
    The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.
  • Active Comparator: Conservative
    Four weeks of splinting followed by mobilisation.
    Intervention: Procedure: Mallet splint for 4 weeks
  • Experimental: Surgery
    Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation.
    Intervention: Procedure: extensor tendon repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • soft tissue mallet finger
  • acute injury

Exclusion Criteria:

  • ASA 3 or above
  • Unable to give informed consent
  • Infection in digit affected
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01016197
PH1
Yes
Not Provided
Not Provided
Mr Philip Holland, Mersey Deanery
Mid Cheshire Hospitals NHS Foundation Trust
Not Provided
Principal Investigator: Philip Holland, MBChB, MRCS National Health Service, United Kingdom
Mid Cheshire Hospitals NHS Foundation Trust
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP