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

Primary Purpose

Distal Radius Fracture, Wrist Fracture

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Early mobilization
Late mobilization
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal radius fracture, Wrist fracture, Physiotherapy, Immobilization, Volar locking plates, Mobilization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Akershus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early mobilization

Late mobilization

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Patient Rated Wrist Evaluation (PRWE)
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)
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)
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)
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)
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
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

Full Information

First Posted
December 10, 2013
Last Updated
August 21, 2020
Sponsor
University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT02015468
Brief Title
The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
Official Title
The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2012 (Actual)
Primary Completion Date
June 17, 2016 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Wrist Fracture
Keywords
Distal radius fracture, Wrist fracture, Physiotherapy, Immobilization, Volar locking plates, Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early mobilization
Arm Type
Experimental
Arm Title
Late mobilization
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Early mobilization
Intervention Description
Early weightbearing and physiotherapy
Intervention Type
Other
Intervention Name(s)
Late mobilization
Intervention Description
Late mobilization, none-weightbearing and home exercises
Primary Outcome Measure Information:
Title
Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)
Description
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.
Time Frame
2 years
Title
Short Form 36 (SF36)
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation (PRWE)
Description
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
Time Frame
2 years
Title
Euro-Qol 5 dimension score (EQ-5d)
Description
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
Time Frame
2 years
Title
Pain Scores on the Visual Analog Scale (VAS)
Description
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
Time Frame
2 years
Title
Radiological findings (X-ray)
Description
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
Time Frame
2 years
Title
Range of motion (ROM)
Description
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
Time Frame
2 yars
Title
Cost analysis
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Erik Madsen, Professor
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Akershus University Hospital
City
Oslo
State/Province
Lorenskog
ZIP/Postal Code
1478
Country
Norway

12. IPD Sharing Statement

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

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