Displaced distal radial fractures in adult patients: Four weeks versus Six weeks of cast immobilization after reduction, a randomized controlled trial.

Displaced distal radial fractures in adult patients: Four weeks versus Six weeks of cast immobilization after reduction, a randomized controlled trial. - DR PIP II - Distal Radius Plaster Immobilization Period II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46494

Enrollment

100

Registered

2018-08-29

Start date

2019-07-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

distal radial fracture forearm fracture wrist fracture

Interventions

patients will be randomized in two study groups: six weeks (control group), or four weeks (intervention group)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 years; 2. Primary displaced unilateral fracture of the distal radius; 3. Independent for activities of daily living.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)