Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger

Patients Present With Mallet Finger Clinical Trial

Official title:

Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02210676
• Other study ID #: 2014P001041
• Status: Withdrawn
• Phase: N/A
• First received: August 5, 2014
• Last updated: December 20, 2016
• Start date: June 2014

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Aim:

The purpose of the study is to learn more about how a person recovers after treatment for mallet finger injury. The investigators want to identify the best outcome after mallet finger injury and how to improve treatment strategies.

Primary null hypothesis:

There are no statistically significant factors associated with extensor lag between 4 weeks and 4 months after immobilization is discontinued for a mallet finger among demographic, injury, and treatment factors.

Secondary null hypothesis:

There are no statistically significant factors associated with PROMIS upper extremity function between 4 weeks and 4 months after completion of immobilization for a mallet finger among demographic, psychological, injury, and treatment factors.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age and older

• English fluency and literacy

• Mallet finger fracture or non-fracture

• Mallet finger subluxation or non-subluxation

Exclusion Criteria:

• Pregnant Women

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Patients Present With Mallet Finger

Intervention

Other:
• PROMIS Upper Extremity

• Likert Pain Scale

• Mallet Finger Extensor Lag Measurement

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mallet Finger Extensor Lag		Baseline	No
Primary	Mallet Finger Extensor Lag		4 weeks to 4 months after diagnosis	No
Secondary	Patient Reported Outcomes Measure Information System (PROMIS) Upper Extremity	A computerized assessment of upper extremity function	4 weeks to 4 months after diagnosis	No
Secondary	Likert Pain Scale		4 weeks to 4 months after diagnosis	No
Secondary	Demographics Questionnaire		4 weeks to 4 months after diagnosis	No