Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-31 @ 7:01 AM
Study NCT ID:
NCT06235957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures
Sponsor:
Spaarne Gasthuis
Organization:
Study Overview
Official Title:
Non- or Minimally Displaced Distal Radius Fractures in Adult Patients <50 Years of Age Treated Non-operatively: Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation a Multicenter Randomised Controlled Trial.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRPIPIII
Brief Summary:
Three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients \<50 years of age treated non-operatively.
Detailed Description:
Background: Currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.
Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.
Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.
Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.
Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: