NCT01016197

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

November 18, 2009

Last Update Submit

September 26, 2016

Conditions

Finger Injury

Keywords

Soft tissue mallet finger

Outcome Measures

Primary Outcomes (1)

  • DASH score

    up to 18 months

Secondary Outcomes (1)

  • Range of movement at distal interphalyngeal joint.

    3, 6, 12 and 18 months

Study Arms (2)

Conservative

ACTIVE COMPARATOR

Four weeks of splinting followed by mobilisation.

Procedure: Mallet splint for 4 weeks

Surgery

EXPERIMENTAL

Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation.

Procedure: extensor tendon repair

Interventions

extensor tendon repairPROCEDURE

Surgical repair of extensor tendon with bone anchor and splinting

Surgery
Mallet splint for 4 weeksPROCEDURE

The patient will wear a "mallet splint" for fours weeks and then mobilise their finger.

Conservative

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • soft tissue mallet finger
  • acute injury

You may not qualify if:

  • ASA 3 or above
  • Unable to give informed consent
  • Infection in digit affected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid Cheshire NHS Trust

Crewe, CW1 4QJ, United Kingdom

Location

MeSH Terms

Conditions

Finger Injuries

Condition Hierarchy (Ancestors)

Hand InjuriesWounds and Injuries

Study Officials

  • Philip Holland, MBChB, MRCS

    National Health Service, United Kingdom

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

GB(1)