Early Mobilization of Operatively Stabilized Distal Radius Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-07-31

Brief Summary

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The purpose of this study is to evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast

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Detailed Description

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All patients with a distal radius fracture treated by surgery (palmar angle stable plate) will be included in this study and randomised into two groups according the CONSORT Guidelines of Prospective Randomised Trails. One group ("early mobilisation") receive a removable plastic cast for one week and are allowed to move the wrist directly postoperative.

The other group ("control group") received a non removable cast for 5 weeks. Both groups underwent physiotherapy two times a week. The control group was only allowed to move the closed-by joints.

In the 6., 9., 12. postoperative week, a half and one year after the operation the patients underwent range of motion (ROM), grip strength measurement and pain according to the visual analogue scale (VAS). Hand function will be analysed according the PRWE (Patient-Rated Wrist Evaluation) Score, DASH (Disabilities of the Arm, Shoulder and Hand) Score and Mayo Wrist Score.

* Inclusion criteria:

* Age ≥ 18 and ≤ 75 years
* A2 - C3 distal radius fracture
* no acute or older injury that influences hand function
* operative stabilized by palmar angle stable plate
* Exclusion criteria:

* Age ≥ 76 years
* Age \< 18 years
* C3.3 radius fracture
* acute or preexisting injures that influences hand function
* pregnancy
* neurologic disorders
* incapacitated people

Conditions

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Closed Fracture of Lower End of Radius and Ulna

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Mobilisation

receives a removable plastic cast for one week and is allowed to move the wrist directly postoperative.

Interventions:

* Range of Motion measurement (ROM),
* Grip strength measurement,
* VAS Score according to the visual analogue scale ().
* Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score.
* X- Rays in two planes.

Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery

Group Type ACTIVE_COMPARATOR

Questionnaire

Intervention Type OTHER

DASH Score, PRWE Score, Mayo Wrist Score

X- Ray

Intervention Type RADIATION

X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery

Grip Strength

Intervention Type OTHER

Grip strength measurement

VAS Score

Intervention Type OTHER

Measurement pain according to the visual analogue scale (VAS)

Range of Motion measurement

Intervention Type OTHER

Angle measurement of the active range of motion in the wrist

Cast Group

receives a non removable cast for 5 weeks

Interventions:

* Range of Motion measurement (ROM),
* Grip strength measurement,
* VAS Score according to the visual analogue scale ().
* Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score.
* X- Rays in two planes.

Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery

Group Type ACTIVE_COMPARATOR

Questionnaire

Intervention Type OTHER

DASH Score, PRWE Score, Mayo Wrist Score

X- Ray

Intervention Type RADIATION

X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery

Grip Strength

Intervention Type OTHER

Grip strength measurement

VAS Score

Intervention Type OTHER

Measurement pain according to the visual analogue scale (VAS)

Range of Motion measurement

Intervention Type OTHER

Angle measurement of the active range of motion in the wrist

Interventions

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Questionnaire

DASH Score, PRWE Score, Mayo Wrist Score

Intervention Type OTHER

X- Ray

X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery

Intervention Type RADIATION

Grip Strength

Grip strength measurement

Intervention Type OTHER

VAS Score

Measurement pain according to the visual analogue scale (VAS)

Intervention Type OTHER

Range of Motion measurement

Angle measurement of the active range of motion in the wrist

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 and ≤ 75 years
* A2 - C3 distal radius fracture
* no acute or older injury that influences hand function
* operative stabilized by palmar angle stable plate

Exclusion Criteria

* Age ≥ 76 years
* Age \< 18 years
* C3.3 radius fracture
* acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No