The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Akershus
Sponsor:
Information provided by (Responsible Party):
Ola-Lars Hammer, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT02015468
First received: December 10, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

A prospective, randomized study investigating the possible benefits of immediate mobilization and frequent physiotherapy following a wrist fracture treated by volar plating.

The current study will test the following null hypothesis:

There is no significant difference between patients who receive a cast for the first 2 weeks postoperatively and then instructions in home exercises and patients who receive a cast for 2-3 days postoperatively and then have frequent sessions with a physiotherapist following volar locked plating for a extraarticular distal radius fracture, as evaluated by self-reported satisfaction after 3 months.


Condition Intervention
Distal Radius Fracture
Wrist Fracture
Other: Early mobilization
Other: Late mobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The Quick-DASH score is a measure of patient reported satisfaction score and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone.

  • Short Form 36 (SF36) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The SF-36 score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone


Secondary Outcome Measures:
  • Patient Rated Wrist Evaluation (PRWE) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The PRWE-score is a measure of patient reported satisfaction and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone

  • Euro-Qol 5 dimension score (EQ-5d) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5d score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone

  • Pain Scores on the Visual Analog Scale (VAS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The VAS-score is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone

  • Radiological findings (X-ray) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Angles, incongruity and other radiological parameters are compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone

  • Range of motion (ROM) [ Time Frame: 2 yars ] [ Designated as safety issue: No ]
    Wrist range of motion is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone

  • Cost analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The cost of treatment, sick-leave, complications and other socioeconomical parameters are compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early mobilization Other: Early mobilization
Early weightbearing and physiotherapy
Experimental: Late mobilization Other: Late mobilization
Late mobilization, none-weightbearing and home exercises

Detailed Description:

The study will focus on patients treated with volar locked plating following an extraarticular distal radius fracture.

In a prospective manner the investigators intend to analyze hand function, x-ray and other parameters in order to investigate whether early mobilization and a targeted program of physiotherapy postoperatively leads to a better functional result and earlier return to a normal activity level. The investigators analysis will also focus on the safety of early mobilization with regards to possible detrimental effects on the osteosynthesis, bony union, associated soft-tissue injuries and functional outcome. The investigators also intend to assess the cost of more intensive follow-up and physiotherapy and do a cost-benefit evaluation.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Position prior to primary reduction:

  • Dorsal tilt > 25°
  • Radial shortening> 6 mm
  • Radial inclination reduced by more than 15°
  • Radiocarpal malalignment > 7 mm
  • Dorsal /volar metaphyseal comminution
  • Volar displacement of the distal fragment(= Smith's fracture)

Position after initial reduction:

  • Dorsal tilt > 5°
  • Radial shortening > 4 mm
  • Radial inclination reduced by more than 10°
  • Radiocarpal malalignment > 4 mm

Exclusion Criteria:

  1. Gustilo-Anderson type III open fractures
  2. Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
  3. Previous distal radius fracture or other disabling injury to the contralateral side
  4. Dementia or other psychiatric illness which affect compliance
  5. Congenital anomaly
  6. Bilateral radius fracture
  7. Concurrent fractures to the upper or lower extremities or other illness which affect movement of the extremities
  8. Systemic joint disease such as rheumatoid arthritis
  9. Patients who do not speak Norwegian
  10. Pathological fracture other than osteoporotic fracture
  11. Congenital bone disease (for example osteogenesis imperfecta)
  12. Age below 18 and above 70
  13. Patients not belonging to Akershus University Hospital
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015468

Locations
Norway
Akershus University Hospital Recruiting
Oslo, Lorenskog, Norway, 1478
Contact: Ola-Lars Hammer, MD    +4767964626    oham@ahus.no   
Sponsors and Collaborators
University Hospital, Akershus
Investigators
Study Director: Jan Erik Madsen, Professor Oslo University Hospital
  More Information

No publications provided

Responsible Party: Ola-Lars Hammer, PhD-student, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02015468     History of Changes
Other Study ID Numbers: 2011/1393A
Study First Received: December 10, 2013
Last Updated: March 21, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by University Hospital, Akershus:
Distal radius fracture
Wrist fracture
Physiotherapy
Immobilization
Volar locking plates
Mobilization

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on September 18, 2014