Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
- Conditions
- Closed Fracture of Lower End of Radius and Ulna
- Interventions
- Other: QuestionnaireRadiation: X- RayOther: Grip StrengthOther: VAS ScoreOther: Range of Motion measurement
- Registration Number
- NCT02312128
- Lead Sponsor
- Ludwig Boltzmann Gesellschaft
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- Age ≥ 76 years
- Age < 18 years
- C3.3 radius fracture
- acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cast Group Questionnaire 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 Early Mobilisation Questionnaire 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 Cast Group Grip Strength 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 Early Mobilisation VAS Score 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 Early Mobilisation Grip Strength 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 Early Mobilisation X- Ray 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 Early Mobilisation Range of Motion measurement 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 Cast Group X- Ray 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 Cast Group VAS Score 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 Cast Group Range of Motion measurement 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
- Primary Outcome Measures
Name Time Method Functional Outcome as measured by visual analogue scale (VAS) one year Pain evaluation according the VAS Score
Functional Outcome as measured by Range of Motion (ROM) one year Range of Motion measured in sagittal plane, frontal plane and forearm rotation
Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score one year Questionnaire: PRWE Score
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score One Year Questionnaire: DASH Score
Functional Outcome as measured by Mayo Wrist Score One year Questionnaire: Mayo Wrist Score
Radiological outcome as measured by X-Ray One Year Radiological outcome in x-ray of the Wrist in two planes
Functional Outcome as measured by Grip Strength one year
- Secondary Outcome Measures
Name Time Method Change Disabilities of the Arm, Shoulder and Hand (DASH) 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 6., 9., 12. week postsurgery, a half and one year after surgery X-Ray of the wrist in two planes
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 Patient-Rated Wrist Evaluation (PRWE) Score 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
Trial Locations
- Locations (1)
Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler
🇦🇹Vienna, Austria