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

NCT ID: NCT02015468

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-15
• Study Completion Date: 2019-01-01

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.

Conditions

Distal Radius Fracture; Wrist Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early mobilization

Group Type: EXPERIMENTAL

Early mobilization

Intervention Type: OTHER

Early weightbearing and physiotherapy

Late mobilization

Group Type: EXPERIMENTAL

Late mobilization

Intervention Type: OTHER

Late mobilization, none-weightbearing and home exercises

Interventions

Early mobilization

Early weightbearing and physiotherapy

Intervention Type: OTHER

Late mobilization

Late mobilization, none-weightbearing and home exercises

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Ola-Lars Hammer

PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Erik Madsen, Professor

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

Akershus University Hospital

Oslo, Lorenskog, Norway

Countries

Norway

Other Identifiers

2011/1393A

Identifier Type: -

Identifier Source: org_study_id