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

Not Applicable

Completed

• Conditions: Distal Radius Fracture; Wrist Fracture
• Interventions: Other: Early mobilization; Other: Late mobilization

• Registration Number: NCT02015468
• Lead Sponsor: University Hospital, Akershus

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.

Study Timeline

• Study Start: 2012-01-15
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Primary Completion: 2016-06-17
• Study Completion: 2019-01-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early mobilization	Early mobilization	-
Late mobilization	Late mobilization	-

Primary Outcome Measures

Name	Time	Method
Short Form 36 (SF36)	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
Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)	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.

Secondary Outcome Measures

Name	Time	Method
Radiological findings (X-ray)	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
Cost analysis	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
Patient Rated Wrist Evaluation (PRWE)	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
Euro-Qol 5 dimension score (EQ-5d)	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
Range of motion (ROM)	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
Pain Scores on the Visual Analog Scale (VAS)	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

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Oslo, Lorenskog, Norway