NCT01388751

Brief Summary

Do patients that night splint for 1 month after 6-8 weeks of continuous splinting for a mallet injury have the same extensor lag 4 months after initiating treatment as patients that do not perform night splinting? Secondary Question: Is night splinting a predictor of DASH score or patient satisfaction (on a 5-Point Likert scale)?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

3.5 years

First QC Date

July 5, 2011

Last Update Submit

October 30, 2012

Conditions

Mallet Finger

Keywords

Mallet Finger splinting

Outcome Measures

Primary Outcomes (1)

  • Extensor Lag

    Null Hypothesis: Patients that night splint for 1 month after 6-8 weeks of continuous splinting for a mallet injury have the same extensor lag 4 months after initiating treatment as patients that do not perform night splinting.

    4 months

Secondary Outcomes (1)

  • DASH score

    4 months

Study Arms (2)

no night splinting

NO INTERVENTION

night splinting

ACTIVE COMPARATOR

Night Splinting for 4 weeks after removal of initial cast

Procedure: night splinting

Interventions

night splintingPROCEDURE

splint finger at night for 4 weeks

night splinting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult, English-speaking patients in the practice of Dr. Jesse Jupiter, Dr. Chaitanya Mudgal, or Dr. David Ring electing splint treatment for mallet deformity will be invited to enroll on their follow-up visit 6-8 weeks after initiating splint treatment.

You may not qualify if:

  • Open lesions
  • Mallet fracture more than 2 weeks old
  • Mallet fracture with subluxation of the distal interphalangeal joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Director of Research, Hand Service

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 7, 2011

Study Start

November 1, 2008

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

US(1)