Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail

Not Applicable

Completed

• Conditions: Closed Fracture of Lower End of Radius and Ulna

• Registration Number: NCT02312128
• Lead Sponsor: Ludwig Boltzmann Gesellschaft

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Study Start: 2015-01
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Outcome as measured by visual analogue scale (VAS)	one year	Pain evaluation according the VAS Score
Functional Outcome as measured by Range of Motion (ROM)	one year	Range of Motion measured in sagittal plane, frontal plane and forearm rotation
Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score	one year	Questionnaire: PRWE Score
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score	One Year	Questionnaire: DASH Score
Functional Outcome as measured by Mayo Wrist Score	One year	Questionnaire: Mayo Wrist Score
Radiological outcome as measured by X-Ray	One Year	Radiological outcome in x-ray of the Wrist in two planes
Functional Outcome as measured by Grip Strength	one year

Secondary Outcome Measures

Name	Time	Method
Change Disabilities of the Arm, Shoulder and Hand (DASH) Score	6., 9., 12. week postsurgery, a half and one year after surgery
Change Mayo Wrist Score	6., 9., 12. week postsurgery, a half and one year after surgery
Change X-Ray	6., 9., 12. week postsurgery, a half and one year after surgery	X-Ray of the wrist in two planes
change Range of motion	6., 9., 12. week postsurgery, a half and one year after surgery
Change Pain	6., 9., 12. week postsurgery, a half and one year after surgery
Change Patient-Rated Wrist Evaluation (PRWE) Score	6., 9., 12. week postsurgery, a half and one year after surgery
Grip strength	6., 9., 12. week postsurgery, a half and one year after surgery

Trial Locations

Locations (1)

Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler; 🇦🇹 Vienna, Austria