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NCT Number: NCT02015468

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fracture Wrist Fractures Wrist Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital

Oslo, Lorenskog, 1478, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • Congenital bone disease (for example osteogenesis imperfecta)
  • Age below 18 and above 70
  • Patients not belonging to Akershus University Hospital

Treatment and study plan

Early mobilization

Other

Early weightbearing and physiotherapy

late mobilization

Other

Late mobilization, none-weightbearing and home exercises

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 2 years

    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

  2. Euro-Qol 5 dimension score (EQ-5d)

    Time frame: 2 years

    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

  3. Pain Scores on the Visual Analog Scale (VAS)

    Time frame: 2 years

    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

  4. Radiological findings (X-ray)

    Time frame: 2 years

    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

  5. Range of motion (ROM)

    Time frame: 2 yars

    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

  6. Cost analysis

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2019
First posted
Dec 19, 2013
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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