BoxerFx: Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06029374
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 29

Study Details

Study Description

Brief Summary

The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture.

Condition or Disease	Intervention/Treatment	Phase
Boxer's Fracture	Procedure: Functional Treatment; Procedure: Forearm Cast and Finger Splint	N/A

Detailed Description

This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture.

Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software "Randomizer" by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment, while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Both groups will receive the allocated bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Functional Treatment	Procedure: Functional Treatment; Patients receiving buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Duration of bandage treatment is determined with 4 weeks.
Active Comparator: Forearm Cast and Finger Splint	Procedure: Forearm Cast and Finger Splint; Patients receiving reduction of fractured finger and subsequent customization of a forearm cast with a finger splint. Duration of cast treatment is determined with 4 weeks.

Outcome Measures

Primary Outcome Measures

1. Brief Michigan-Hand-Outcome-Questionnaire [at 12 weeks]

   patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)

Secondary Outcome Measures

1. Loss/Gain of Reduction [at 12 weeks]

   changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees)

2. Treatment Failure [at 1, 2, 4 and 12 weeks]

   Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition

Other Outcome Measures

1. Visual Analogue Scale (VAS) [at 0, 1, 2, 4 and 12 weeks]

   Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)

2. Strength Measurement [at 4 and 12 weeks]

   dynamometer-based strength evaluation

3. Range of Motion (ROM) Assessment [at 4 and 12 weeks]

   goniometer-based ROM evaluation of hand and wrist

4. Delayed Bone Healing [at 12 weeks]

   number of participants with bone non-union at end of study

5. Radiological Outcome [at 0, 1, 2, 4 and 12 weeks]

   x-ray based outcome of fracture healing in terms of axial deviation (measured in °)

6. Radiological Outcome [at 0, 1, 2, 4 and 12 weeks]

   x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)

7. Quick DASH-Score [at 0, 1, 2, 4 and 12 weeks]

   patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)

8. Brief Michigan-Hand-Outcome-Questionnaire [at 0, 1, 2 and 4 weeks]

   patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)

9. Occurrence of Complications [at 0, 1, 2, 4 and 12 weeks]

   occurence of complications due to treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Fifth Metacarpal Neck Fractures

• Patient age between 18 and 70 years

Exclusion Criteria:

• Palmar angulation >50° in first lateral x-ray

• Pathologic fracture

• Intraarticular fracture

• Patients unable to consent

• Polytraumatized patients

• Pregnancy

• Compound fractures

• Multiple hand injuries

• Patients initially presenting more than 7 days after injury

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Study Director: Gerhild Thalhammer, M.D., Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul L Hoppe, M.D., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT06029374
• Other Study ID Numbers: 1529/2023
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 8, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone

Study Results

No Results Posted as of Sep 8, 2023