Is routine radiography following the initial 2-week follow-up of trauma patients with wrist and ankle fractures necessary?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29076

Enrollment

418

Registered

2014-05-26

Start date

2014-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

distal radius fractures, ankle fractures pols fracturen, enkel fracturen

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

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 wr

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

Eligibility

Inclusion criteria

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

Exclusion criteria: - Psychiatric conditions; - Pathological fractures; - Complicated fractures (Gustilo grade 2 & 3); - Multi-extremity fractures; - Unable to complete follow-up

Design outcomes

Primary

Measure	Time frame
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). For wrist fractures the Disabilities of the Arm, Shoulder and Hand Score (DASH).	—

Secondary

Measure	Time frame
- Functional status measured with the American Academy of Orthopaedic Surgeons foot and ankle questionnaire (AAOS) and the Patient Rated Wrist/Hand Evaluation (PRWHE); - Costs; - Pain; - Health-related quality of life (HRQoL); - Self-perceived recovery; - Range of motion - Complications	—

Contacts

Public ContactP. van Gerven

Leiden University Medical Center Datacenter Heelkunde, K6-R P.O. Box 9600

p.van_gerven@lumc.nl+31715297981

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)