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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Mid Cheshire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01016197
First received: November 18, 2009
Last updated: September 26, 2016
Last verified: September 2016
  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
Procedure: Mallet splint for 4 weeks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial

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

Primary Outcome Measures:
  • DASH score [ Time Frame: up to 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 ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conservative
Four weeks of splinting followed by mobilisation.
Procedure: Mallet splint for 4 weeks
The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.
Experimental: Surgery
Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation.
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   (Child, Adult, Senior)
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016197

Locations
United Kingdom
Mid Cheshire NHS Trust
Crewe, United Kingdom, CW1 4QJ
Sponsors and Collaborators
Mid Cheshire Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Philip Holland, MBChB, MRCS National Health Service, United Kingdom
  More Information

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: September 26, 2016
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 December 07, 2016