Clinical trial NCT02894983: Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial
Official title: Comparison of Volar-flexion, Ulnar-deviation and Functional Position Cast Immobilization in the Non-operative Treatment of Distal Radius Fracture in Elderly Patients: a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colles' Fracture
Distal Radius Fracture
Keywords: wrist fracture
colles fracture
non-operative
rehabilitation
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
name: Satakunta Central Hospital
First posted: 2016-09-09
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
* Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Exclusion Criteria:

* Operative treatment
* 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, forearm or elbow

Primary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study
timeFrame: 2 years
Secondary outcomes:
measure: Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
timeFrame: 2 years
measure: Quality of life measured with the 15-D.
timeFrame: 2 years
measure: Pain measured in Visual Analogue Scale (VAS).
timeFrame: Baseline, 3 months, 1 year, 2 years
measure: Range of motion (ROM) is measured with a goniometer
timeFrame: 3 months
measure: Grip strength is measured with a dynamometer
timeFrame: 3 months
measure: The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.
timeFrame: 2 years
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Tampere
country: Finland
facility: Tampere Univeristy Hospital
Study officials:
affiliation: Tampere Univeristy Hospital
name: Ville Mattila, MD, Professor
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Antti Launonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Teemu Hevonkorpi, MBBS
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Lauri Raittio, MBBS
role: STUDY_CHAIR
affiliation: Central Finland Central Hospital
name: Toni Luokkala, MD
role: STUDY_CHAIR
affiliation: Central Finland Central Hospital
name: Aleksi Reito, MD, PhD
role: STUDY_CHAIR
affiliation: Satakunta Central Hospital
name: Juha Kukkonen, MD, PhD
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Minna Laitinen, Adjacent prof
role: STUDY_CHAIR
References:
citation: Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.
citation: Raittio L, Launonen A, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Sumrein B, Laitinen M, Mattila VM. Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol. BMC Musculoskelet Disord. 2017 Sep 18;18(1):401. doi: 10.1186/s12891-017-1759-y.