Clinical trial NCT02879656: Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years
Official title: Non-operative Treatment Versus Surgery With Volar Locking Plate in Treatment of Distal Radius Fracture in 65-year-old and Older Patients - a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
name: Satakunta Central Hospital
name: Regionshospitalet Viborg, Skive
First posted: 2016-08-26
Enrollment: 291
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present collaboration study on the treatment of distal radius fractures is aimed to:

(i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE

(ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE

(iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture

(iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture

(v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures

(vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome

(vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS


Eligibility criteria: Inclusion Criteria:

* low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anterior radiographs in ER
* \>10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph

Exclusion Criteria:

* Refuse to participate the study
* Open fracture more than Gustilo 1 gradus
* Age under 65 years
* Chauffeure's or Barton´s fracture
* Smith´s fracture (volar angulation of the fracture)
* Does not understand written and spoken guidance in local languages
* Pathological fracture or previous fracture in the same wrist or forearm

Primary outcomes:
measure: Change over time in Patient Rated Wrist Evaluation (PRWE)
timeFrame: 3 months, 1 year, 2 years
Secondary outcomes:
measure: Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire
timeFrame: 3 months, 1 year, 2 years
measure: Quality of life measured with the 15-D
timeFrame: Baseline, 3 months, 1 year, 2 years
measure: Pain measured in Visual Analogue Scale (VAS)
timeFrame: 3 months, 1 year, 2 years
measure: Grip strength measured with a dynamometer
timeFrame: 3 months, 1 year
measure: Pain catastrophizing measured with the pain catastrophizing scale (PCS)
timeFrame: baseline, 3 months, 1 year, 2 years
measure: Physical activity measured with Axivity accelerometer
timeFrame: 3 months, 1 year
measure: Self-assessment
timeFrame: Baseline, 1 year, 2 years
measure: EWC
timeFrame: Baseline
measure: Frailty
timeFrame: Baseline
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital
city: Pori
country: Finland
facility: Pori Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Ville Mattila, Prof
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Antti Launonen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Minna Laitinen, adjunct prof
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Teemu Hevonkorpi, MD
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Lauri Raittio, MD
role: STUDY_CHAIR
affiliation: Central Finland Central Hospital
name: Toni Luokkala, MD
role: STUDY_CHAIR
affiliation: Central Finland Central Hospital
name: Aleksi Reito, MD
role: STUDY_CHAIR
affiliation: Satakunta Central Hospital
name: Juha Kukkonen, MD
role: STUDY_CHAIR
affiliation: Karolinska University Hospital
name: Li Felländer-Tsai, MD
role: STUDY_CHAIR
References:
citation: Hevonkorpi TP, Launonen AP, Raittio L, Luokkala T, Kukkonen J, Reito A, Sumrein BO, Laitinen MK, Mattila VM; NITEP-group. Nordic Innovative Trial to Evaluate OsteoPorotic Fractures (NITEP-group): non-operative treatment versus surgery with volar locking plate in the treatment of distal radius fracture in patients aged 65 and over - a study protocol for a prospective, randomized controlled trial. BMC Musculoskelet Disord. 2018 Apr 5;19(1):106. doi: 10.1186/s12891-018-2019-5.