Clinical trial NCT02312128: Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
Official title: Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Fracture of Lower End of Radius and Ulna
Keywords: distal radius fractures
early mobilization
postoperative treatment
outcome
Lead sponsor: Ludwig Boltzmann Gesellschaft
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Institute for Experimental und Clinical Traumatology
First posted: 2014-12-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Functional Outcome as measured by visual analogue scale (VAS)
timeFrame: one year
measure: Functional Outcome as measured by Range of Motion (ROM)
timeFrame: one year
measure: Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score
timeFrame: one year
measure: Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: One Year
measure: Functional Outcome as measured by Mayo Wrist Score
timeFrame: One year
measure: Radiological outcome as measured by X-Ray
timeFrame: One Year
measure: Functional Outcome as measured by Grip Strength
timeFrame: one year
Secondary outcomes:
measure: change Range of motion
timeFrame: 6., 9., 12. week postsurgery, a half and one year after surgery
measure: Change Pain
timeFrame: 6., 9., 12. week postsurgery, a half and one year after surgery
measure: Change Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 6., 9., 12. week postsurgery, a half and one year after surgery
measure: Change Patient-Rated Wrist Evaluation (PRWE) Score
timeFrame: 6., 9., 12. week postsurgery, a half and one year after surgery
measure: Change Mayo Wrist Score
timeFrame: 6., 9., 12. week postsurgery, a half and one year after surgery
measure: Change X-Ray
timeFrame: 6., 9., 12. week postsurgery, a half and one year after surgery
measure: Grip strength
timeFrame: 6., 9., 12. week postsurgery, a half and one year after surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler
Study officials:
affiliation: AUVA Traumazentrum Vienna Site UKH Meidling
name: Stefan Quadlbauer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AUVA Traumazentrum Vienna Site UKH Meidling
name: Martin Leixnering, M.D.
role: STUDY_DIRECTOR
References: