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

U

University Hospital, Akershus

Status

Completed

Conditions

Wrist Fracture
Distal Radius Fracture

Treatments

Other: Late mobilization
Other: Early mobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT02015468
2011/1393A

Details and patient eligibility

About

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.

Full 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.

Enrollment

116 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

116 participants in 2 patient groups

Early mobilization
Experimental group
Treatment:
Other: Early mobilization
Late mobilization
Experimental group
Treatment:
Other: Late mobilization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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