Clinical trial NCT02015468: The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
Official title: The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Wrist Fracture
Keywords: Distal radius fracture
Wrist fracture
Physiotherapy
Immobilization
Volar locking plates
Mobilization
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)
timeFrame: 2 years
measure: Short Form 36 (SF36)
timeFrame: 2 years
Secondary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 2 years
measure: Euro-Qol 5 dimension score (EQ-5d)
timeFrame: 2 years
measure: Pain Scores on the Visual Analog Scale (VAS)
timeFrame: 2 years
measure: Radiological findings (X-ray)
timeFrame: 2 years
measure: Range of motion (ROM)
timeFrame: 2 yars
measure: Cost analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Akershus University Hospital
state: Lorenskog
Study officials:
affiliation: Oslo University Hospital
name: Jan Erik Madsen, Professor
role: STUDY_DIRECTOR
References: