This trial is active, not recruiting.

Conditions distal radius fracture, wrist fracture
Treatments early mobilization, late mobilization
Sponsor University Hospital, Akershus
Start date January 2012
End date December 2016
Trial size 120 participants
Trial identifier NCT02015468, 2011/1393A


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
early mobilization
Early weightbearing and physiotherapy
late mobilization
Late mobilization, none-weightbearing and home exercises

Primary Outcomes

Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)
time frame: 2 years
Short Form 36 (SF36)
time frame: 2 years

Secondary Outcomes

Patient Rated Wrist Evaluation (PRWE)
time frame: 2 years
Euro-Qol 5 dimension score (EQ-5d)
time frame: 2 years
Pain Scores on the Visual Analog Scale (VAS)
time frame: 2 years
Radiological findings (X-ray)
time frame: 2 years
Range of motion (ROM)
time frame: 2 yars
Cost analysis
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital, Akershus.