Clinical trial NCT05150925: Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Official title: Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Keywords: distal radius fracture
volar plating
surgery
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.

Detailed description: This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.

Eligibility criteria: Inclusion Criteria:

* Intra- or extra articular DRF (Colles, Smith, Volar barton)
* operative treatment justified

Exclusion Criteria:

* Refusal to participate in the study
* Open fracture with a severity greater than Gustilo grade 1
* Patient aged less than 18 or over 65
* Patient does not understand written or spoken guidance in local languages
* Pathological fracture
* Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
* Ipsilateral fracture in upper extremity
* Associated fractures of the ulna (except fractures of the PSU)
* Polytrauma

Primary outcomes:
measure: Patient-rated wrist evaluation questionnaire
timeFrame: 2 months
measure: Total lenght of the sick leave
timeFrame: 12 months
Secondary outcomes:
measure: Patient-rated wrist evaluation questionnaire
timeFrame: 4 weeks
measure: Patient-rated wrist evaluation questionnaire
timeFrame: 6 months
measure: Patient-rated wrist evaluation questionnaire
timeFrame: 12 months
measure: Return to work
timeFrame: 4 weeks
measure: Return to work
timeFrame: 2 months
measure: Return to work
timeFrame: 6 months
measure: Return to work
timeFrame: 12 months
measure: Complications
timeFrame: 4 weeks
measure: Complications
timeFrame: 2 months
measure: Complications
timeFrame: 6 months
measure: Complications
timeFrame: 12 months
measure: Self-perceived working ability
timeFrame: 4 weeks
measure: Self-perceived working ability
timeFrame: 2 months
measure: Self-perceived working ability
timeFrame: 6 months
measure: Self-perceived working ability
timeFrame: 12 months
measure: Visual analogue pain scale
timeFrame: 4 weeks
measure: Visual analogue pain scale
timeFrame: 2 months
measure: Visual analogue pain scale
timeFrame: 6 months
measure: Visual analogue pain scale
timeFrame: 12 months
measure: Patient-acceptable symptom state
timeFrame: 2 months
measure: Patient-acceptable symptom state
timeFrame: 6 months
measure: Patient-acceptable symptom state
timeFrame: 12 months
measure: Work capacity
timeFrame: 4 weeks
measure: Work capacity
timeFrame: 2 months
measure: Work capacity
timeFrame: 6 months
measure: Work capacity
timeFrame: 12 months
Other outcomes:
measure: Patient activity
timeFrame: 4 weeks
Locations:
city: Jyväskylä
country: Finland
facility: Teemu Karjalainen
city: Tampere
country: Finland
facility: Laura Kärnä
Study officials:
affiliation: Tampere University Hospital
name: Aleksi Reito
role: STUDY_DIRECTOR
References:
citation: Karna L, Launonen AP, Karjalainen T, Luokkala T, Ponkilainen V, Halonen L, Helminen M, Mattila VM, Reito A. LIMPER trials: immediate mobilisation versus 2-week cast immobilisation after distal radius fracture treated with volar locking plate - a study protocol for a prospective, randomised, controlled trial. BMJ Open. 2022 Nov 11;12(11):e064440. doi: 10.1136/bmjopen-2022-064440.