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

Finger Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01016197
• Other study ID #: PH1
• Status: Withdrawn
• Phase: N/A
• First received: November 18, 2009
• Last updated: September 26, 2016
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2016
• Source: Mid Cheshire Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• soft tissue mallet finger

• acute injury

Exclusion Criteria:

• ASA 3 or above

• Unable to give informed consent

• Infection in digit affected

Study Design

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

Related Conditions & MeSH terms

• Finger Injuries
• Finger Injury

Intervention

Procedure:
• extensor tendon repair
Surgical repair of extensor tendon with bone anchor and splinting
• Mallet splint for 4 weeks
The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.

Locations

Country	Name	City	State
United Kingdom	Mid Cheshire NHS Trust	Crewe

Sponsors (1)

Lead Sponsor	Collaborator
Mid Cheshire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH score		up to 18 months	No
Secondary	Range of movement at distal interphalyngeal joint.		3, 6, 12 and 18 months	No