Actively Recruiting
Led by Tampere University Hospital · Updated on 2026-01-21
532
Participants Needed
10
Research Sites
208 weeks
Total Duration
T
Tampere University Hospital
Lead Sponsor
K
Kuopio University Hospital
Collaborating Sponsor
This research evaluates treatment methods for older adults aged 65 years or older who have displaced distal radius fractures caused by low-energy injuries. It compares casting without prior closed reduction to casting after closed reduction to see if they provide equivalent results in wrist pain and disability after 12 months. The study is a randomized controlled trial including 532 participants and led by Tampere University Hospital, focusing on the Patient-Rated Wrist Evaluation (PRWE) score as the primary measure. Participants are randomly assigned to one of two groups: one receiving a dorsal cast without reduction right after the initial x-ray, and the other undergoing closed reduction under local anesthesia followed by casting. Both groups have their casts removed after 5 weeks and are encouraged to resume normal wrist use without restrictions. An observational group receiving standard care without randomization is also followed remotely. Follow-up visits occur at 3 and 12 months, with radiographs taken at 3 months only. Participants will attend follow-up appointments in person or remotely, completing questionnaires and wearing accelerometer wristbands if remote. Data is collected via the REDCap system. Outcomes measured include wrist function, pain, quality of life, and adverse events. Patients with ongoing symptoms may receive physiotherapy for up to one year and further evaluation if needed. A 5-year follow-up is planned as an exploratory endpoint to monitor long-term results.
CONDITIONS
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive either a dorsal cast without reduction or closed reduction followed by casting for their distal radius fracture. The cast is removed after 5 weeks, and participants are advised to resume everyday use of the injured wrist without restrictions.
Cast removal at 1 visit (in-person) at the health center or hospital outpatient clinic
Duration - 12 months
Participants meet research personnel at 3 months and 12 months for follow-up assessments. Radiographs are taken at 3 months only. Follow-up visits may be in-person or remote, including questionnaires and telephone interviews to collect outcome data.
2 visits (in-person or remote) at 3 months and 12 months with questionnaires and interviews
Duration - Up to 1 year
Participants may undergo physiotherapy rehabilitation for up to one year if symptoms persist. If symptoms do not improve, further evaluation and possible procedures such as CT scans or surgery may be considered.
Visits as needed depending on symptoms and rehabilitation progress
Total: 10 locations
1
Viborg regional Hospital
Viborg, Denmark
Actively Recruiting
2
Tartu University Hospital
Tartu, Estonia
Actively Recruiting
3
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33520
Actively Recruiting
4
Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00260
Actively Recruiting
5
Kanta-Häme Central Hospital
Hämeenlinna, Finland
Actively Recruiting
6
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
7
Oulu University Hospital
Oulu, Finland, 90220
Actively Recruiting
8
Pori Central Hospital
Pori, Finland
Not Yet Recruiting
9
Turku University Hospital
Turku, Finland
Not Yet Recruiting
10
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
L
Laura Kärnä, MD
V
Ville Ponkilainen, MD, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Laura Kärnä, Ville Ponkilainen, Aleksi Reito...
https://pubmed.ncbi.nlm.nih.gov/41101953