|- candidate number||17959|
|- NTR Number||NTR4610|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mei-2014|
|- Secondary IDs||P14.086 |
|- Public Title||Is routine radiography following the initial
2-week follow-up of trauma patients with wrist and ankle fractures necessary?|
|- Scientific Title||Is routine radiography following the initial
2-week follow-up of trauma patients with wrist and ankle fractures necessary?
|- hypothesis||We hypothesize that a reduction of the current radiographic follow-up protocol for patients with ankle and wrist fractures will lead to significant cost savings without compromising quality of care|
|- Healt Condition(s) or Problem(s) studied||Wrist fracture, Ankle fracture|
|- Inclusion criteria||- Adult (> 18 years); |
- Fracture of the ankle (uni-or bimalleolar fractures /Lauge-Hansen classification SA II, SE II-IV, PA I-IV) or fracture of the distal radius (AO classification type A-C);
- Sufficient understanding of the Dutch language
|- Exclusion criteria||- Psychiatric conditions;|
- Pathological fractures;
- Complicated fractures (Gustilo grade 2 & 3);
- Multi-extremity fractures;
- Unable to complete follow-up
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2014|
|- planned closingdate||31-dec-2016|
|- Target number of participants||418|
|- Interventions||Group 1 is to receive usual care according to the current national protocol, indicating clinical follow-up as well as radiographic evaluations, which shall take place in the outpatient clinics at 1, 2, 6, and 12 weeks.
Group 2 is to receive the same clinical evaluations as the usual care group (see above); however, no routine radiographs will be performed beyond the initial 2 weeks. Radiography during follow-up will be allowed (10% estimated), if any of the following are present: 1) new trauma to the wrist or ankle; 2) pain > 6 based upon the visual analogue scale (11-point VAS); 3) loss of range of motion (ROM) > 20 degrees; 4) neurovascular symptoms; or 5) at the discretion of the clinician
|- Primary outcome||The primary outcome is area-specific functional status, which for both types of fracture will be measured using Dutch versions of the following questionnaires:
For ankle fractures the Olerud and Molander ankle score (OMAS) and the American Academy of Orthopaedic Surgeons foot and ankle questionnaire (AAOS) will be used.
For wrist fractures the Disabilities of the Arm, Shoulder and Hand Score (DASH) and the Patient Rated Wrist/Hand Evaluation (PRWHE) will be used.
|- Secondary outcome||- Costs|
- Health-related quality of life (HRQoL);
- Self-perceived recovery;
- Range of motion
|- Timepoints||Follow-up at 1,2,6 and 12 weeks, 6 months and 1 year|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. N.L. Weil|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD M.F. Termaat|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background: Extremity fractures such as ankle and wrist fractures are a common and costly health care problem affecting all age groups. The management of patients with these fractures depends on fracture type and loss of congruity of the involved joint; resulting in cast immobilization or operative treatment. Loss of congruity or displacement leading to uneven joint loading, osteoarthritis and a increased probability of a poor functional outcome, should be identified within the first 2 weeks following trauma, based upon conventional radiographic imaging to determine optimal treatment. After this period, routine radiographs and clinical assessments are often scheduled for monitoring the bone-healing process and clinical outcomes, respectively. Many currently used protocols for timing of radiographic assessment describe standard imaging at 1, 2, 6 and 12 weeks following baseline. However, it is questionable whether routine radiography following the initial follow-up (i.e. 2-weeks post trauma) is cost-effective. |
The aim of this study is to investigate whether a reduction of the current radiographic follow-up protocol in patients with uncomplicated wrist or ankle fractures leads to significant cost savings without compromising quality of care.
Methods/design: In a multicentre randomized controlled non-inferiority trial, 418 patients aged 18 years or older will be included, of whom 279 ankle fracture patients and 139 wrist fracture patients. Patients will be randomized in 2 groups. Group 1 is to receive usual care, consisting of routine radiographs at baseline and after 1, 2, 6 and 12 weeks of follow-up. Group 2 is to receive radiographs beyond the initial 2-week follow-up only when clinically indicated. Primary outcome is the extremity-specific functional status, measured using web-based questionnaires. For the ankle fractures the Olerud and Molander ankle score and the American Academy of Orthopaedic Surgeons Foot and Ankle questionnaire will be used. For the wrist fractures, the Disabilities of the Arm, Shoulder and Hand Score and the Patient Rated Wrist and Hand Evaluation will be used. Secondary outcomes include: pain intensity, health-related quality of life, self-perceived recovery, and complications such as bone infections, nonunion, malunion, implant failure and costs. Both groups will be monitored clinically at 1,2,6, and 12 weeks and at 6 and 12 months.
Discussion: This study will provide data on (cost-)effectiveness of routine radiography in the follow-up of uncomplicated ankle and wrist fractures, without compromising the quality of care and could pave the way for a change in (inter)national protocols.
|- Main changes (audit trail)|
|- RECORD||26-mei-2014 - 10-jul-2014|