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

Recruiting

Conditions: colles' fracture
wrist fracture
10017322

Registration Number: NL-OMON37606

Lead Sponsor: Kennemer Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 132

Inclusion Criteria

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p> Range of motion<br /><br><br /><br>A goniometer is used for the measurement of the flexibility of wrist and finger<br /><br>joint of the healthy hand and injured hand not sooner than 7 weeks after closed<br /><br>reduction. And also at 9,15 and 26 weeks extension, flexion, pronation and<br /><br>suppination will be measured.<br /><br><br /><br>Anatomical evaluation<br /><br><br /><br>Postero-anterior and lateral radiographs are used to determine radial tilt,<br /><br>ulnar variance and palmar tilt before reduction and immediately after and at<br /><br>follow-up. (at 5 days, 10 days, 5 weeks)<br /><br><br /><br>Acceptable anatomical positions:<br /><br>- Radial shortening: level radius >= level ulna<br /><br>- Normal articulation distal radio-ulnar joint (DRUJ)<br /><br>- Dorsal angulation 10* until -20<br /><br>- Radial inclination > 15 and < 35*</p><br>