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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015468
• Other study ID #: 2011/1393A
• Status: Completed
• Phase: N/A
• Start date: January 15, 2012
• Est. completion date: January 1, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 1, 2019
• Est. primary completion date: June 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fracture

Intervention

Other:
• Early mobilization
Early weightbearing and physiotherapy
• Late mobilization
Late mobilization, none-weightbearing and home exercises

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Oslo	Lorenskog

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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