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

NCT02312128 | Completed

• 1 other identifier: 03/2010
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Closed Fracture of Lower End of Radius and Ulna

Keywords

distal radius fractures; early mobilization; postoperative treatment; outcome

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• 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

Study Arms (2)

Early Mobilisation

ACTIVE COMPARATOR

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; Radiation: X- Ray; Other: Grip Strength; Other: VAS Score; Other: Range of Motion measurement

Cast Group

ACTIVE COMPARATOR

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; Radiation: X- Ray; Other: Grip Strength; Other: VAS Score; Other: Range of Motion measurement

Interventions

Questionnaire OTHER

DASH Score, PRWE Score, Mayo Wrist Score

Cast Group; Early Mobilisation

X- Ray RADIATION

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

Cast Group; Early Mobilisation

Grip Strength OTHER

Grip strength measurement

Cast Group; Early Mobilisation

VAS Score OTHER

Measurement pain according to the visual analogue scale (VAS)

Cast Group; Early Mobilisation

Range of Motion measurement OTHER

Angle measurement of the active range of motion in the wrist

Cast Group; Early Mobilisation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig Boltzmann Gesellschaft: lead
• Ludwig Boltzmann Institute for Experimental und Clinical Traumatology: collaborator

Study Sites (1)

Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler

Vienna, 1200, Austria

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Surveys and Questionnaires; X-Rays; Hand Strength

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stefan Quadlbauer, M.D.

  AUVA Traumazentrum Vienna Site UKH Meidling

  PRINCIPAL INVESTIGATOR

• Martin Leixnering, M.D.

  AUVA Traumazentrum Vienna Site UKH Meidling

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 9, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

AU (1)