Early Range of Motion in 5th Metacarpal Fracture

NCT02441790 | Withdrawn DMC

• 1 other identifier: NIF-2013-07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Fractures of the fifth metacarpal neck are the most common injury involving the upper extremity. Patients are typically young adult males. Restoring function quickly and reliably for return to work and/or activity is important; these patients are a significant labour force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting a fracture is a "trade-off". Immobilization allows stabilization and fracture healing, but also causes hand stiffness and weakness leading to impaired function. Little prospective research exists; there is no agreement for ideal duration of splinting or therapy, demonstrating clinical equipoise. A new concept in hand rehabilitation is "early active range of motion" (EAROM). The objective of this trial is to establish if EAROM provides improved early (6 week) hand function when compared to standard immobilization.

Conditions

Fracture

Keywords

5th metacarpal; EAROM; standard immobilization; Boxer's Fracture; hand function; DASH; trauma

Outcome Measures

Primary Outcomes (1)

• Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure

  6 weeks

Secondary Outcomes (1)

• HR-QOL

  3, 6 and 12 months

Study Arms (2)

Early Active Range of Motion

EXPERIMENTAL

Early Active Range of Motion (EAROM) 3-9 days following hand fracture

Behavioral: Early Active Range of Motion

Standard Immoblization

ACTIVE COMPARATOR

Standard immobilization with plaster splint for 21-27 following hand fracture

Behavioral: Standard Immobilization

Interventions

Early Active Range of Motion BEHAVIORAL

3-9 days

Early Active Range of Motion

Standard Immobilization BEHAVIORAL

21-27 days

Standard Immoblization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or greater than 18 years
• Fifth metacarpal neck fracture, 9 or fewer days since injury
• Equal or less than 40 degrees of dorsal fracture angulation on lateral x-ray. Angle is measured between the line along the longitudinal axis of the metacarpal shaft and the line from the centre of the metacarpal head to the fracture site.
• No angulation or malrotation
• No clinical fracture shortening (ie. Inability to extend fifth digit)
• Non-operative treatment
• Volar or ulnar gutter splint (MCP flexed, IPs extended)

You may not qualify if:

• Metabolic bone disease
• "Open fracture" with soft tissue loss overlying fracture site
• Tendon injury
• Neurovascular injury
• Clinical rotatory malalignment
• Fracture shortening demonstrated by "pseudoclawing"
• Other fracture in the ipsilateral upper extremity
• Any operative indication
• Previous fracture to the involved fifth ray

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Fractures, Bone; Wounds and Injuries

Study Officials

• Michael James Cooper, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

CA (1)