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Conservative Treatment of Mallet Finger Injury

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ClinicalTrials.gov Identifier: NCT04830917
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Lori Algar, Orthopaedic Specialty Group PC, Fairfield

Study Description
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Brief Summary:
Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.

Condition or disease Intervention/treatment Phase
Conservatively Treated Mallet Finger Injury Other: Immobilization type for mallet injury Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment with Kinesiotape and Oval 8 Other: Immobilization type for mallet injury
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury
Experimental: Treatment with quick cast Other: Immobilization type for mallet injury
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury


Outcome Measures
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Primary Outcome Measures :
  1. Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit [ Time Frame: 12 weeks from injury ]

Secondary Outcome Measures :
  1. Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit [ Time Frame: 6 months post injury ]
  2. Brief Michigan Hand Outcome Questionnaire [ Time Frame: 12 weeks from injury ]
  3. Brief Michigan Hand Outcome Questionnaire [ Time Frame: 6 months post injury ]
  4. Satisfaction on a visual analog scale (0-10) [ Time Frame: 12 weeks from injury ]
  5. Satisfaction on a visual analog scale (0-10) [ Time Frame: 6 months post injury ]
  6. Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit [ Time Frame: 12 week post injury ]
  7. Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit [ Time Frame: 6 months post injury ]
  8. Pain according to a numeric pain rating scale (0-10/10) [ Time Frame: 12 weeks after injury ]
  9. Pain according to a numeric pain rating scale (0-10/10) [ Time Frame: 6 months post injury ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age

Exclusion Criteria:

  • previous injury to the involved digit impacting ROM
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830917


Contacts
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Contact: Lori A Algar, OTD 203-451-4938 lori.algar@gmail.com

Locations
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United States, Connecticut
Orthopaedic Specialty Group PC Recruiting
Fairfield, Connecticut, United States, 06825
Contact: Lori A Algar, OTD    203-451-4938    lori.algar@gmail.com   
Sponsors and Collaborators
Orthopaedic Specialty Group PC, Fairfield
More Information
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Responsible Party: Lori Algar, Hand therapist/occupational therapist, Orthopaedic Specialty Group PC, Fairfield
ClinicalTrials.gov Identifier: NCT04830917    
Other Study ID Numbers: SVMC 17-328
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Finger Injuries
Hand Injuries