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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture; Wrist Fracture
• Intervention / Treatment: Other: Early mobilization; Other: Late mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Lorenskog
    • Oslo, Lorenskog, Norway, 1478
      • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early mobilization	Other: Early mobilization; Early weightbearing and physiotherapy
Experimental: Late mobilization	Other: Late mobilization; Late mobilization, none-weightbearing and home exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years
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	2 years
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	2 years
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	2 years
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	2 yars
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	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Study Director: Jan Erik Madsen, Professor, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2012
• Primary Completion (Actual): June 17, 2016
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Physiotherapy; Distal radius fracture; Mobilization; Immobilization; Wrist fracture; Volar locking plates
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 2011/1393A