Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Functional Outcome as measured by visual analogue scale (VAS)
研究概览
简要总结
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
详细描述
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.
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Inclusion criteria:
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Age ≥ 18 and ≤ 75 years
-
A2 - C3 distal radius fracture
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no acute or older injury that influences hand function
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operative stabilized by palmar angle stable plate
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Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age ≥ 76 years
- •Age < 18 years
- •C3.3 radius fracture
- •acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people
研究组 & 干预措施
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
干预措施: Questionnaire (Other)
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
干预措施: X- Ray (Radiation)
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
干预措施: Grip Strength (Other)
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
干预措施: VAS Score (Other)
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
干预措施: Range of Motion measurement (Other)
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
干预措施: Questionnaire (Other)
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
干预措施: X- Ray (Radiation)
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
干预措施: Grip Strength (Other)
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
干预措施: VAS Score (Other)
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
干预措施: Range of Motion measurement (Other)
结局指标
主要结局
Functional Outcome as measured by visual analogue scale (VAS)
时间窗: one year
Pain evaluation according the VAS Score
Functional Outcome as measured by Range of Motion (ROM)
时间窗: 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
时间窗: one year
Questionnaire: PRWE Score
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score
时间窗: One Year
Questionnaire: DASH Score
Functional Outcome as measured by Mayo Wrist Score
时间窗: One year
Questionnaire: Mayo Wrist Score
Radiological outcome as measured by X-Ray
时间窗: One Year
Radiological outcome in x-ray of the Wrist in two planes
Functional Outcome as measured by Grip Strength
时间窗: one year
次要结局
- Change Mayo Wrist Score(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 X-Ray(6., 9., 12. week postsurgery, a half and one year after surgery)
- 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)
研究者
Stefan Quadlbauer, M.D.
M.D.
AUVA Traumazentrum Vienna Site UKH Meidling