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

Closed Fracture of Lower End of Radius and Ulna Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312128
• Other study ID #: 03/2010
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: February 2019
• Source: Ludwig Boltzmann Gesellschaft
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Closed Fracture of Lower End of Radius and Ulna
• Fractures, Bone
• Fractures, Closed
• Radius Fractures
• Ulna Fractures

Intervention

Other:
• Questionnaire
DASH Score, PRWE Score, Mayo Wrist Score

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

Other:
• Grip Strength
Grip strength measurement
• VAS Score
Measurement pain according to the visual analogue scale (VAS)
• Range of Motion measurement
Angle measurement of the active range of motion in the wrist

Locations

Country	Name	City	State
Austria	Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig Boltzmann Gesellschaft	Ludwig Boltzmann Institute for Experimental und Clinical Traumatology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcome as measured by visual analogue scale (VAS)	Pain evaluation according the VAS Score	one year
Primary	Functional Outcome as measured by Range of Motion (ROM)	Range of Motion measured in sagittal plane, frontal plane and forearm rotation	one year
Primary	Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score	Questionnaire: PRWE Score	one year
Primary	Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score	Questionnaire: DASH Score	One Year
Primary	Functional Outcome as measured by Mayo Wrist Score	Questionnaire: Mayo Wrist Score	One year
Primary	Radiological outcome as measured by X-Ray	Radiological outcome in x-ray of the Wrist in two planes	One Year
Primary	Functional Outcome as measured by Grip Strength		one year
Secondary	change Range of motion		6., 9., 12. week postsurgery, a half and one year after surgery
Secondary	Change Pain		6., 9., 12. week postsurgery, a half and one year after surgery
Secondary	Change Disabilities of the Arm, Shoulder and Hand (DASH) Score		6., 9., 12. week postsurgery, a half and one year after surgery
Secondary	Change Patient-Rated Wrist Evaluation (PRWE) Score		6., 9., 12. week postsurgery, a half and one year after surgery
Secondary	Change Mayo Wrist Score		6., 9., 12. week postsurgery, a half and one year after surgery
Secondary	Change X-Ray	X-Ray of the wrist in two planes	6., 9., 12. week postsurgery, a half and one year after surgery
Secondary	Grip strength		6., 9., 12. week postsurgery, a half and one year after surgery