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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02015468
Enrollment
116
Registered
2013-12-19
Start date
2012-01-15
Completion date
2019-01-01
Last updated
2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture, Wrist Fracture

Keywords

Distal radius fracture, Wrist fracture, Physiotherapy, Immobilization, Volar locking plates, Mobilization

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.

Interventions

OTHEREarly mobilization

Early weightbearing and physiotherapy

Late mobilization, none-weightbearing and home exercises

Sponsors

University Hospital, Akershus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short version of Disabilities of the Arm, Shoulder and Hand (Quick-DASH)2 yearsThe 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.
Short Form 36 (SF36)2 yearsThe 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

Secondary

MeasureTime frameDescription
Pain Scores on the Visual Analog Scale (VAS)2 yearsThe VAS-score is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Radiological findings (X-ray)2 yearsAngles, 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
Patient Rated Wrist Evaluation (PRWE)2 yearsThe 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
Cost analysis2 yearsThe 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
Range of motion (ROM)2 yarsWrist 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
Euro-Qol 5 dimension score (EQ-5d)2 yearsThe 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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026