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Functional outcome of conservative treatment of distal radius fractures: Dorsal flexion versus palmar flexion, the D-FLEX trial. A prospective randomized controlled trial

Functional outcome of conservative treatment of distal radius fractures: Dorsal flexion versus palmar flexion, the D-FLEX trial. A prospective randomized controlled trial - D-FLEX trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37606
Enrollment
132
Registered
2012-07-02
Start date
2012-11-27
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

colles' fracture wrist fracture

Interventions

Both groups are treated in the same way as far as anaesthesie and reduction were concerned. The only difference in treatment lay in the position of fixation in cast. Group 1: the wrist immobilized i

Sponsors

Kennemer Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: > 18 years of age Displaced colles' fracture Normal wristfunction before fracture

Exclusion criteria

Exclusion criteria: 1. A history of wristfracture 2. bilateral wrist fracture 3. Antebrachi fracture type (combination with ulna, proc. stiloideus excluded) 4.palmarly angulated fracture 5. open fracture or tendon/nerve/vascular lesions 6. fracture more than 5 days old 7. Marked comminution or displacement considered for primary surgical fixation 8. Degenerative musculoskeletal disease (osteoporosis excluded) 9. Those who are unable to give written informed consent (mentally disabled, language problem)

Design outcomes

Primary

MeasureTime frame
Disabilities of the Arm, Shoulder and Hand score (quick DASH-score) Quick DASH is a self-administered questionnaire that was developed in Canada in 2006, and can be used instead of the full DASH with similar precision (gummeson). This short version can improve the response rate (Abramo). A Dutch version has been validated for use in upper extremity disorders. The questionnaire consists of 11 questions evaluating different aspects of physical activity, severity of symptoms and the effect of the injury on social activities. A score is calculated and the disability of the patient is estimated on a scale from 0 to 100, with 100 being the worst result. The patients are asked to complete the form on week 7,9 15 en 26.

Secondary

MeasureTime frame
Range of motion A goniometer is used for the measurement of the flexibility of wrist and finger joint of the healthy hand and injured hand not sooner than 7 weeks after closed reduction. And also at 9,15 and 26 weeks extension, flexion, pronation and suppination will be measured. Anatomical evaluation Postero-anterior and lateral radiographs are used to determine radial tilt, ulnar variance and palmar tilt before reduction and immediately after and at follow-up. (at 5 days, 10 days, 5 weeks) Acceptable anatomical positions: - Radial shortening: level radius >= level ulna - Normal articulation distal radio-ulnar joint (DRUJ) - Dorsal angulation 10* until -20* - Radial inclination > 15* and

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)