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Clinical Trials/NCT02015468
NCT02015468
Completed
Not Applicable

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

University Hospital, Akershus1 site in 1 country116 target enrollmentJanuary 15, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
University Hospital, Akershus
Enrollment
116
Locations
1
Primary Endpoint
Short Form 36 (SF36)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2012
End Date
January 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Akershus
Responsible Party
Principal Investigator
Principal Investigator

Ola-Lars Hammer

PhD-student

University Hospital, Akershus

Eligibility 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

Exclusion Criteria

  • Gustilo-Anderson type III open fractures
  • Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
  • Previous distal radius fracture or other disabling injury to the contralateral side
  • Dementia or other psychiatric illness which affect compliance
  • Congenital anomaly
  • Bilateral radius fracture
  • Concurrent fractures to the upper or lower extremities or other illness which affect movement of the extremities
  • Systemic joint disease such as rheumatoid arthritis
  • Patients who do not speak Norwegian
  • Pathological fracture other than osteoporotic fracture

Outcomes

Primary Outcomes

Short Form 36 (SF36)

Time Frame: 2 years

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

Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)

Time Frame: 2 years

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.

Secondary Outcomes

  • Radiological findings (X-ray)(2 years)
  • Cost analysis(2 years)
  • Patient Rated Wrist Evaluation (PRWE)(2 years)
  • Euro-Qol 5 dimension score (EQ-5d)(2 years)
  • Range of motion (ROM)(2 yars)
  • Pain Scores on the Visual Analog Scale (VAS)(2 years)

Study Sites (1)

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