NCT02015468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

4.4 years

First QC Date

December 10, 2013

Last Update Submit

August 21, 2020

Conditions

Distal Radius FractureWrist Fracture

Keywords

Distal radius fractureWrist fracturePhysiotherapyImmobilizationVolar locking platesMobilization

Outcome Measures

Primary Outcomes (2)

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

    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 years

  • Short Form 36 (SF36)

    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

    2 years

Secondary Outcomes (6)

  • Patient Rated Wrist Evaluation (PRWE)

    2 years

  • Euro-Qol 5 dimension score (EQ-5d)

    2 years

  • Pain Scores on the Visual Analog Scale (VAS)

    2 years

  • Radiological findings (X-ray)

    2 years

  • Range of motion (ROM)

    2 yars

  • +1 more secondary outcomes

Study Arms (2)

Early mobilization

EXPERIMENTAL
Other: Early mobilization

Late mobilization

EXPERIMENTAL
Other: Late mobilization

Interventions

Early mobilizationOTHER

Early weightbearing and physiotherapy

Early mobilization
Late mobilizationOTHER

Late mobilization, none-weightbearing and home exercises

Late mobilization

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Oslo, Lorenskog, 1478, Norway

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Jan Erik Madsen, Professor

    Oslo University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 19, 2013

Study Start

January 15, 2012

Primary Completion

June 17, 2016

Study Completion

January 1, 2019

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

NO(1)