No registrations found.
ID
Source
Brief title
Health condition
distal radius fracture
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiological degree of radiocarpal osteoarthritis using the SLAC classification.
Secondary outcome
• Patient-Rated Wrist Evaluation score (PRWE)
• Disability of the Arm, Shoulder and Hand (DASH)
• Michigan Hand Outcome Questionnaire (MHOQ)
• Pain Catastrophizing Scale (PCS)
• 15D
• Quality of life (EQ-5D)
• Costs questionnaire
• ROM (range of motion)
• Grip strength
• Complications
• Radiographic parameters
• Frailty score (Groningen Frailty indicator)
Background summary
Rationale: Continuing controversy exists in the best treatment of intra-articular distal radius fractures in the elderly. The ultimate aim of treatment is to restore articular congruity to prevent complications such as secondary post-traumatic osteoarthritis. Treatment of choice depends highly on the surgeon’s preference and functional demands of the elderly patient. Currently, the development of post-traumatic osteoarthritis is unclear regarding the relation to trauma as well as regarding the best treatment. Furthermore, the development of osteoarthritis in relation to the healthy contralateral side (which projects the natural course of osteoarthritis) and in relation to functional outcomes in the elderly are not known.
Objective: Assessing the post traumatic and degenerative radio-carpal osteoarthritis of open reduction and internal fixation compared with non-operative treatment for elderly patients with an intra-articular distal radius fracture.
Study design: A prospective cohort study with a four year follow up study on the DART study (The effectiveness of surgery versus casting for elderly patients with Displaced distal intra-Articular Radius fractures. A randomized controlled Trial).
Study population: Subjects of the DART study (patients aged between 65 years and older with displaced intra-articular distal radius fractures, with an inacceptable reduction fracture characteristics within 3 weeks following trauma).
Intervention (if applicable): Not applicable. Patients have been randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group) during the DART study.
Main study parameters/endpoints: The degree of radio-carpal osteoarthritis will be evaluated 2 and 5 years after the intra-articular distal radius fracture on X-ray and on CT scan. An assessment will be made if there is a correlation between the primary outcome and secondary outcomes, such as patient reported outcome measures (PROMs) including the Patient-Rated Wrist Evaluation score (PRWE), Disability of the Arm, Shoulder and Hand (DASH), Michigan Hand Outcome Questionnaire (MHOQ), Quality of life (EQ-5D and 15D) and Pain Catastrophizing Scale (PCS). Further secondary outcomes are the frailty score, range of motion (ROM), grip strength, complications and additional costs as a result of osteoarthritis.
Study objective
• Cast treatment is not inferior to surgical open reduction internal fixation in terms of post-traumatic radio-carpal osteoarthritis and patient related outcome measurements.
• No correlation is present between the radiological degree of post-traumatic radio-carpal osteoarthritis and functional outcomes.
Study design
T1: 2 years post trauma
T2: 2.5 years post trauma (only EQ-5D, costs questionnaire)
T3: 3 years post trauma (only EQ-5D, costs questionnaire)
T4: 3.5 years post trauma (only EQ-5D, costs questionnaire)
T5: 4 years post trauma (only EQ-5D, costs questionnaire)
T6: 4.5 years post trauma (only EQ-5D, costs questionnaire)
T7: 5 years post trauma
Intervention
X-rays of both wrist
CT-scans of both wrists
Inclusion criteria
• Participant of the DART study
• Mentally competent
• Dutch fluency and literacy
• Informed consent
Exclusion criteria
• Participants of the DART study who did not complete the follow-up period
• Fracture of the contralateral wrist in the history
• Rheumatoid arthritis
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7308 |
NTR-old | NTR7524 |
CCMO | NL67693.098.18 |
OMON | NL-OMON49854 |