Nowadays, many dislocated fractures of the distal radius will be treated operatively. However, a significant amount of dislocated distal radial fractures do not need operative treatment and will be treated by reduction and immobilization. Usually an…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the PRWE (Patient Related Wrist Evaluation)
score after one year.
PRWE score is the most responsive instrument for evaluating the outcome in
patients with distal radius fractures. The PRWE is a validated 15-item (scored
1-10), self-reported questionnaire designed to help describe the disability
experienced by people with disorders of the wrist and also to monitor changes
in symptoms and function over time. Scores will be transformed to a 0-100
score. A higher score indicates greater disability.
Secondary outcome
1. The QuickDASH (Disabilities of the Arm, Shoulder and Hand) and SF-36 score
after one year;16
2. Functional outcome after 8 weeks, 3 months and 6 months ;
3. Range of motion;
4. Pain level after 8 weeks, 3 months, 6 months and 1 year;
5. Lidström-score;
6. Fracture related complications: Number of secondary dislocations after cast
removal; Number of re-interventions;Delayed-/nonunion; CRPS.
Subjective functional outcome will be measured by QuickDash and PRWE. Range of
motion will be measured using a goniometer. Pain level will be measured by a
pain dairy [Appendix VI] and determined using a 10-point Visual Analog Scale
(VAS), in which zero implies no pain and ten implies the worst possible pain.
Radiological outcome and the amount of dislocation will be assessed by an
independent radiologist by use of the Lidström-score [Appendix VII]. Delayed-
or nonunion will be defined as an delay of arrest in fracture healing after 3
or 6 months, respectively.
In addition to the outcome variables mentioned above, the following data will
be collected: Intrinsic variables (baseline data): Age, gender, hand
dominance, body weight, smoking, occupation, hobbies, sporting activities.
Background summary
Up to 30% of patients with a dislocated distal radius fracture suffer from
long-term functional restrictions following conservative treatment. It remains
unclear, whether duration of cast immobilisation influences functional outcome.
Study objective
Nowadays, many dislocated fractures of the distal radius will be treated
operatively. However, a significant amount of dislocated distal radial
fractures do not need operative treatment and will be treated by reduction and
immobilization. Usually an immobilization period of five or six weeks is
preferred as non-operative treatment of reduced distal radial fractures.
Despite the minimal evidence in literature this immobilization period can be
questioned. A randomized clinical trial with sufficient power is needed to
provide scientific support for a preferred treatment strategy for reduced
distal radial fractures. The aim of this trial is to compare the results of
four weeks of cast immobilization with six weeks of cast immobilization of
reduced distal radial fractures with respect to functional outcome, the
incidence of non-union, pain scores and complications.
Study design
This study will be conducted as a multi-center prospective randomized clinical
trial in two large size teaching hospitals . In this study four weeks of
plaster immobilization is compared with six weeks of plaster immobilization.
Patients will be treated in a lower arm cast. Post cast treatment will be the
same for both groups, in which additional physiotherapy is advised and
exercises to train wrist function will be given [Appendix I]. The study will
start immediately after approval of METC.
Intervention
patients will be randomized in two study groups: six weeks (control group), or
four weeks (intervention group)
Study burden and risks
Both periods of immobilization are generally accepted ways of treatment.
up to 30% of patients with a dislocated distal radius fracture suffer from
long-term functional restrictions following conservative treatment. The
duration of immobilization of distal radius fractures depends on whether these
fractures can be considered stable fractures, besides type of fracture and age
of the patient most distal radial fractures are liable to displace within the
first two weeks, only 7% to 8% displace after this time, and none after six
weeks. The chance of secondary dislocation after removal of the cast after
four weeks seems to be negligible.
Boelelaan 1117
Amsterdam 1007MB
NL
Boelelaan 1117
Amsterdam 1007MB
NL
Listed location countries
Age
Inclusion criteria
1. Age > 18 years;
2. Primary displaced unilateral fracture of the distal radius;
3. Independent for activities of daily living.
Exclusion criteria
1. Fracture of contralateral wrist;
2. Ipsilateral fractures proximal of the DRF;
3. Pre-existent abnormalities or functional deficits of the fractured wrist;
4. Open fractures.
5. Language ability to understand the Dutch patient information and questionnaires.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62861.029.17 |