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.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The degree of radio-carpal osteoarthritis on X-ray and and CT scan 2 and 5
years after the intra-articular distal radius fracture.
Secondary outcome
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-3L 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.
Background summary
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.
Study 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) (NL56858.100.16, R16.013/DART).
Study burden and risks
All study patients of the DART study will be approached and asked to
participate in the DART II study. As part of the DART II, patients will have
two follow-up moments at 24 months and 60 months. Patients will be asked to
fill out the questionnaires, both wrists will be physically examined and X-rays
of both wrists will be made. Furthermore, at 60 months follow up, a CT scan
will be made of both wrists. Patients are also asked to fill out a cost
questionnaire combined with the EQ-5D-3L every six months. In total study
participants will spend 210 minutes to this study.
Exposure to radiation due to the extra radiographs and CT scan of the wrists is
relatively low. In total it will result in approximately 0,044 mSv of
radiation.
Reinier de Graafweg 5
Delft 2625 AD
NL
Reinier de Graafweg 5
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
Participant of the DART study or NITEP Nordic Radius study (AO type C fracture)
Mentally competent
Dutch fluency and literacy
Informed consent
Exclusion criteria
Incomplete follow-up period during participation of the DART study
Fracture of the contralateral wrist in the history
Rheumatoid arthritis
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03009890 |
| CCMO | NL67693.098.18 |
| OMON | NL-OMON26024 |