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

Ludwig Boltzmann Gesellschaft

Status: Completed

Conditions: Closed Fracture of Lower End of Radius and Ulna

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02312128

03/2010

Details and patient eligibility

About

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

Full 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

Enrollment: 116 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Early Mobilisation

Active Comparator group

Description:

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

Treatment:

Radiation: X- Ray

Other: Questionnaire

Other: VAS Score

Other: Range of Motion measurement

Other: Grip Strength

Cast Group

Active Comparator group

Description:

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

Treatment:

Radiation: X- Ray

Other: Questionnaire

Other: VAS Score

Other: Range of Motion measurement

Other: Grip Strength