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
Sponsor:
Information provided by:
Mid Cheshire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01016197
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Finger Injury
Procedure: extensor tendon repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mid Cheshire Hospitals NHS Foundation Trust:

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: 50
Study Start Date: January 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: extensor tendon repair
    Surgical repair of extensor tendon with bone anchor and splinting
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • soft tissue mallet finger
  • acute injury

Exclusion Criteria:

  • ASA 3 or above
  • Unable to give informed consent
  • Infection in digit affected
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mr Philip Holland, Mersey Deanery
ClinicalTrials.gov Identifier: NCT01016197     History of Changes
Other Study ID Numbers: PH1
Study First Received: November 18, 2009
Last Updated: November 18, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Mid Cheshire Hospitals NHS Foundation Trust:
Soft tissue mallet finger

Additional relevant MeSH terms:
Finger Injuries
Hand Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014