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

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

Study Overview

• Status: Completed
• Conditions: Closed Fracture of Lower End of Radius and Ulna
• Intervention / Treatment: Other: Questionnaire; Radiation: X- Ray; Other: Grip Strength; Other: VAS Score; Other: Range of Motion measurement

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1200
    • Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Other: VAS Score; Measurement pain according to the visual analogue scale (VAS); Other: Range of Motion measurement; Angle measurement of the active range of motion in the wrist
Active Comparator: 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	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; Other: VAS Score; Measurement pain according to the visual analogue scale (VAS); Other: Range of Motion measurement; Angle measurement of the active range of motion in the wrist

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Disabilities of the Arm, Shoulder and Hand (DASH) Score		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
Change Mayo Wrist Score		6., 9., 12. week postsurgery, a half and one year after surgery
Change X-Ray	X-Ray of the wrist in two planes	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

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Gesellschaft
• Collaborators: Ludwig Boltzmann Institute for Experimental und Clinical Traumatology
• Investigators: Principal Investigator: Stefan Quadlbauer, M.D., AUVA Traumazentrum Vienna Site UKH Meidling; Study Director: Martin Leixnering, M.D., AUVA Traumazentrum Vienna Site UKH Meidling

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: outcome; early mobilization; distal radius fractures; postoperative treatment
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Fractures, Closed; Radius Fractures
• Other Study ID Numbers: 03/2010